Neuromuscular Block
Conditions
Keywords
Onset, Recovery, Lidocaine, Cisatracurium, Magnesium sulfate, Isotonic solution
Brief summary
The magnesium sulfate and lidocaine have been increasingly used alone or in combination during anesthesia procedure to meet various objectives, such as reduction of pain, use of smaller anesthetic doses and stabilization of hemodynamic parameters. These medicines are often used in combination with neuromuscular blocking agents, which may contribute to the occurrence of residual block in some patients after anesthetic procedures. It was estimated that only 1-3 % of patients with residual block developing clinically apparent events. In a small proportion of patients, the consequences of residual blockade are very serious and even lethal. It is estimated that 40 % of patients with muscle paralysis come to the post-anesthesia care unit (PACU). Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of applications in various areas of medicine, (b) these medications stand out for their properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been important part of the therapeutic arsenal to control a large number of diseases (d) the patient surgical surgery or potentially have benefited in particular from its effects, (and) these drugs have been used routinely in many medical services as well as adjuvants in anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the duration of neuromuscular blockade by different types of muscle relaxants, with controversies about its effect on latency (g) the effect of lidocaine on the action of muscle relaxants in current literature have shown great controversy and (h) do not exist in the literature studies involving both drugs; the investigators aimed to investigate the effects of magnesium sulphate infused alone or associated with lidocaine on the neuromuscular blockade promoted by cisatracurium, as well as evaluate its possible hemodynamic repercussions. For this purpose the SM was infused in bolus, prior to tracheal intubation and continuously during the maintenance of general anesthesia; the Lidocaine, when associated and the Isotonic Solution were used in the same way and timeline as SM. As secondary objectives it has been proposed to evaluate if the Lidocaine with Magnesium Sulfate would be able to interfere with the hemodynamic stability of the patients in the study.
Detailed description
The study was approved by the Medical Research Ethics Committee of the Hospital das Clinicas, of the Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Brazil; Its Unique Protocol ID is 5362/2013. This study was conducted with free written informed consent from the study subjects. This report describes a prospective randomized clinical trial. The author states that the report includes every item in the checklist for a prospective randomized clinical trial. The study was registered prior to patient enrollment. Forty-eight American Society of Anesthesiology patient classification status ASA I and II undergoing elective surgery were divided into three parallel groups. The M group received MS 40 mg.kg-1 as a bolus before the induction of anesthesia and 20mg.kg-1h-1 via continuous i.v. infusion during the operation period. The ML group received identical doses of MS combined with lidocaine 3 mg.kg-1 as a bolus before the induction of anesthesia and 3 mg.kg-1h-1 via continuous i.v. infusion during the operation period. The control group was administered a equivalent volume of isotonic solution. Anesthesia was maintained via propofol and remifentanil infusions. After loss of patient consciousness and administration of the bolus infusions, a 0.15 mg.kg-1 bolus of cisatracurium was administered to the patient over 5 s. No additional cisatracurium injections were performed. The patient's neuromuscular function was assessed every 15 s by measuring the adductor polis with a TOF Watch SX acceleromyograph. The primary endpoint was the time at which spontaneous recovery of a train-of-four (TOF) ratio of 90% as achieved. The systolic, diastolic and mean and heart rate were recorded and annotated at various times: M1- when the patient arrived in the operating room; M2- immediately before induction of anesthesia; M3- before the infusion of the tested solutions (saline, magnesium sulphate or magnesium sulphate associated with lidocaine); M4- five minutes after M3 (end of infusion loading dose of test solutions); M5 immediately before intubation; M6- one minute after tracheal intubation and M7 (a through f) - every fifteen minutes until the end of the study. The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of the neuromuscular blockade (NMB). Quantitative variables were described as mean ± standard deviation. The normality of the distributions was tested for all variables in each group, using the non-parametric test of Shapiro-Wilk. When the variable normally distributed, we used the analysis of variance test (ANOVA) for comparison between groups. When differences were found between the groups, we used the Tukey test for multiple comparisons. When the variable is not normally distributed by applying the Shapiro-Wilk test, we used the Kruskal-Wallis test to compare the groups. When differences were found between the groups, we used the Dunn test for multiple comparisons. The critical level of significance was 5%. During the analysis of the recovery characteristics of the neuromuscular blockade, all parameters based on the T1 response (DUR 25% DUR 75% and DUR 95%) were normalized considering the final T1 value when this response did not return to baseline (VIBY-MOGENSEN et al., 1996).
Interventions
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Before the recruitment of patients, the study was approved by Brazil Platform (a national and unified basis of research involving human subjects records) and published by the ClinicalTrials.gov Inclusion Criteria: * ASA I or II * BMI between 18 and 29
Exclusion criteria
* Use of medications that could affect the neuromuscular blockade such as calcium channel inhibitors, anticonvulsants and lithium carbonate * Presence of neuromuscular, renal or hepatic dysfunction. * Hypermetabolic or hypometabolic states such as fever, infection, and hyperthyroidism or hypothyroidism * Acid-base disorder, congestive heart failure or conductive heart problems, and those who were being treated for cardiac arrhythmias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency | Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes | The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium. This outcome meansure was presented in seconds. |
| Clinical Duration | Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes | The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium. This outcome meansure was presented in minutes. |
| Recovery Index | Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes | The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium. This outcome meansure was presented in minutes. |
| Final Recovery Index | Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes | The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium. This outcome measure was presented in minutes. |
| Total Duration (Dur95%) | Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes | The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium. This outcome measure was presented in minutes. |
| Spontaneous Recovery (T4/T1=90%) | The participants were followed during the anesthetic - surgical procedure | Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium. This outcome measure was presented in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HR - M1 (Heart Rate in the Moment 1) | This measure of heart rate was performed when the patient arrived in the operating room | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'. |
| HR - M2 (Heart Rate in the Moment 2) | This measure of heart rate was performed immediately before induction of anesthesia | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'. |
| HR - M3 (Heart Rate in the Moment 3) | This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution) | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'. |
| HR - M4 (Heart Rate in the Moment 4) | This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion) | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'. |
| HR - M5 (Heart Rate in the Moment 5) | This measure of heart rate was performed immediately before the tracheal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'. |
| HR - M6 (Heart Rate in the Moment 6) | This measure of heart rate was performed one minute after the tracheal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'. |
| MAP - M7a (Mean Arterial Pressure in the Moment 7a) | This measure of average blood pressure was performed 15 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'. |
| MAP - M7b (Mean Arterial Pressure in the Moment 7b) | This measure of average blood pressure was performed 30 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'. |
| MAP - M7c (Mean Arterial Pressure in the Moment 7c) | This measure of average blood pressure was performed 45 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'. |
| MAP - M1 (Mean Arterial Pressure in the Moment 1) | This measure of average blood pressure was performed when the patient arrived in the operating room | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'. |
| MAP - M7e (Mean Arterial Pressure in the Moment 7e) | This measure of average blood pressure was performed 75 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'. |
| MAP - M7f (Mean Arterial Pressure in the Moment 7f) | This measure of average blood pressure was performed 90 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'. |
| HR - M7a (Heart Rate in the Moment 7a) | This measure of heart rate was performed 15 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'. |
| HR - M7b (Heart Rate in the Moment 7b) | This measure of heart rate was performed 30 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'. |
| HR - M7c (Heart Rate in the Moment 7c) | This measure of heart rate was performed 45 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'. |
| HR - M7d (Heart Rate in the Moment 7d) | This measure of heart rate was performed 60 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'. |
| HR - M7e (Heart Rate in the Moment 7e) | This measure of heart rate was performed 75 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'. |
| HR - M7f (Heart Rate in the Moment 7f) | This measure of heart rate was performed 90 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'. |
| MAP - M7d (Mean Arterial Pressure in the Moment 7d) | This measure of average blood pressure was performed 60 minutes after the traqueal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'. |
| MAP - M2 (Mean Arterial Pressure in the Moment 2) | This measure of average blood pressure was performed immediately before induction of anesthesia | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'. |
| MAP - M3 (Mean Arterial Pressure in the Moment 3) | This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution) | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'. |
| MAP - M4 (Mean Arterial Pressure in the Moment 4) | This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion) | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'. |
| MAP - M5 (Mean Arterial Pressure in the Moment 5) | This measure of average blood pressure was performed immediately before the tracheal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'. |
| MAP - M6 (Mean Arterial Pressure in the Moment 6) | This measure of average blood pressure was performed one minute after the tracheal intubation | In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'. |
Participant flow
Recruitment details
After approval by the Research Ethics Committee, 48 patients were selected for the study. Patients were invited to participate in the study during the pre-anesthetic evaluation, at which were told about the objectives, benefits and risks of research and those who agreed to participate signed the free consent form.
Participants by arm
| Arm | Count |
|---|---|
| Group M Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery
Magnesium Sulfate | 16 |
| Group ML Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery
Magnesium Sulfate
Lidocaine | 16 |
| Group C Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups
Isotonic Solution | 15 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Group M | Group ML | Group C | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 15 Participants | 47 Participants |
| Region of Enrollment Brazil | 16 participants | 16 participants | 15 participants | 47 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 15 |
Outcome results
Primary
Clinical Duration
The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium. This outcome meansure was presented in minutes.
Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes
Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by Kruskal-Wallis test. When differences were found between the groups, we used the Dunn test for multiple comparisons (p value \< 0.05)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | Clinical Duration | 82.68 minutes |
| Group ML | Clinical Duration | 86.33 minutes |
| Group C | Clinical Duration | 64.8 minutes |
p-value: <0.000195% CI: [71.78, 140.6]Kruskal-Wallis
p-value: <0.000195% CI: [72.62, 99.27]Kruskal-Wallis
p-value: <0.000195% CI: [40.5, 92.9]Kruskal-Wallis
Primary
Final Recovery Index
The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium. This outcome measure was presented in minutes.
Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes
Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | Final Recovery Index | 27.97 minutes | Standard Deviation 6.77 |
| Group ML | Final Recovery Index | 33.81 minutes | Standard Deviation 10.97 |
| Group C | Final Recovery Index | 21.51 minutes | Standard Deviation 3.28 |
p-value: 0.000395% CI: [19.5, 41.5]ANOVA
p-value: 0.000395% CI: [18.5, 49.5]ANOVA
p-value: 0.000395% CI: [17.5, 30.05]ANOVA
Primary
Latency
The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium. This outcome meansure was presented in seconds.
Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes
Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | Latency | 139.70 seconds | Standard Deviation 47.92 |
| Group ML | Latency | 151.30 seconds | Standard Deviation 47.97 |
| Group C | Latency | 147.80 seconds | Standard Deviation 29.75 |
p-value: 0.965195% CI: [88, 235]ANOVA
p-value: 0.965195% CI: [78, 244]ANOVA
Comparison: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.p-value: 0.965195% CI: [105, 200]ANOVA
Primary
Recovery Index
The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium. This outcome meansure was presented in minutes.
Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes
Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | Recovery Index | 20.08 minutes | Standard Deviation 6.49 |
| Group ML | Recovery Index | 20.26 minutes | Standard Deviation 7.69 |
| Group C | Recovery Index | 14.53 minutes | Standard Deviation 1.52 |
p-value: 0.001595% CI: [12, 32.25]ANOVA
p-value: 0.001595% CI: [10.5, 39.83]ANOVA
p-value: 0.001595% CI: [11, 16.5]ANOVA
Primary
Spontaneous Recovery (T4/T1=90%)
Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium. This outcome measure was presented in minutes.
Time frame: The participants were followed during the anesthetic - surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | Spontaneous Recovery (T4/T1=90%) | 120.20 minutes | Standard Deviation 10.88 |
| Group ML | Spontaneous Recovery (T4/T1=90%) | 126.70 minutes | Standard Deviation 14.19 |
| Group C | Spontaneous Recovery (T4/T1=90%) | 90.03 minutes | Standard Deviation 12.78 |
p-value: <0.000195% CI: [106.3, 140.2]ANOVA
p-value: <0.000195% CI: [106.5, 149.4]ANOVA
p-value: <0.000195% CI: [71.75, 116.4]ANOVA
Primary
Total Duration (Dur95%)
The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium. This outcome measure was presented in minutes.
Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes
Population: The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value \< 0.05)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | Total Duration (Dur95%) | 113.20 minutes | Standard Deviation 12.16 |
| Group ML | Total Duration (Dur95%) | 120.10 minutes | Standard Deviation 18.2 |
| Group C | Total Duration (Dur95%) | 88.19 minutes | Standard Deviation 16.34 |
p-value: <0.000195% CI: [94.87, 136.8]ANOVA
p-value: <0.000195% CI: [95.82, 163.3]ANOVA
p-value: <0.000195% CI: [58, 125.2]ANOVA
Secondary
HR - M1 (Heart Rate in the Moment 1)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.
Time frame: This measure of heart rate was performed when the patient arrived in the operating room
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M1 (Heart Rate in the Moment 1) | 79.94 beats/min | Standard Deviation 15.79 |
| Group ML | HR - M1 (Heart Rate in the Moment 1) | 77.25 beats/min | Standard Deviation 12.13 |
| Group C | HR - M1 (Heart Rate in the Moment 1) | 73.66 beats/min | Standard Deviation 11.82 |
p-value: 0.433895% CI: [52, 109]ANOVA
p-value: 0.433895% CI: [55, 95]ANOVA
p-value: 0.433895% CI: [55, 92]ANOVA
Secondary
HR - M2 (Heart Rate in the Moment 2)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.
Time frame: This measure of heart rate was performed immediately before induction of anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M2 (Heart Rate in the Moment 2) | 74.69 beats/min | Standard Deviation 11.76 |
| Group ML | HR - M2 (Heart Rate in the Moment 2) | 73.69 beats/min | Standard Deviation 11.18 |
| Group C | HR - M2 (Heart Rate in the Moment 2) | 75.40 beats/min | Standard Deviation 11.54 |
p-value: 0.916795% CI: [57, 99]ANOVA
p-value: 0.916795% CI: [51, 96]ANOVA
p-value: 0.916795% CI: [53, 90]ANOVA
Secondary
HR - M3 (Heart Rate in the Moment 3)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.
Time frame: This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M3 (Heart Rate in the Moment 3) | 72.94 beats/min | Standard Deviation 10.96 |
| Group ML | HR - M3 (Heart Rate in the Moment 3) | 74.19 beats/min | Standard Deviation 8.65 |
| Group C | HR - M3 (Heart Rate in the Moment 3) | 75.40 beats/min | Standard Deviation 11.54 |
p-value: 0.806795% CI: [58, 92]ANOVA
p-value: 0.806795% CI: [57, 86]ANOVA
p-value: 0.806795% CI: [53, 90]ANOVA
Secondary
HR - M4 (Heart Rate in the Moment 4)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.
Time frame: This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M4 (Heart Rate in the Moment 4) | 71.94 beats/min | Standard Deviation 10.87 |
| Group ML | HR - M4 (Heart Rate in the Moment 4) | 72.25 beats/min | Standard Deviation 9.78 |
| Group C | HR - M4 (Heart Rate in the Moment 4) | 65.07 beats/min | Standard Deviation 10.01 |
p-value: 0.101595% CI: [57, 93]ANOVA
p-value: 0.101595% CI: [52, 89]ANOVA
p-value: 0.101595% CI: [44, 81]ANOVA
Secondary
HR - M5 (Heart Rate in the Moment 5)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.
Time frame: This measure of heart rate was performed immediately before the tracheal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M5 (Heart Rate in the Moment 5) | 67.56 beats/min | Standard Deviation 10.05 |
| Group ML | HR - M5 (Heart Rate in the Moment 5) | 69.31 beats/min | Standard Deviation 7.73 |
| Group C | HR - M5 (Heart Rate in the Moment 5) | 64.27 beats/min | Standard Deviation 10.81 |
p-value: 0.342395% CI: [56, 92]ANOVA
p-value: 0.342395% CI: [57, 83]ANOVA
p-value: 0.342395% CI: [41, 81]ANOVA
Secondary
HR - M6 (Heart Rate in the Moment 6)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.
Time frame: This measure of heart rate was performed one minute after the tracheal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M6 (Heart Rate in the Moment 6) | 66.50 beats/min | Standard Deviation 10.11 |
| Group ML | HR - M6 (Heart Rate in the Moment 6) | 68.19 beats/min | Standard Deviation 8.4 |
| Group C | HR - M6 (Heart Rate in the Moment 6) | 65.13 beats/min | Standard Deviation 10.5 |
p-value: 0.681795% CI: [53, 92]ANOVA
p-value: 0.681795% CI: [54, 82]ANOVA
p-value: 0.681795% CI: [47, 81]ANOVA
Secondary
HR - M7a (Heart Rate in the Moment 7a)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.
Time frame: This measure of heart rate was performed 15 minutes after the traqueal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M7a (Heart Rate in the Moment 7a) | 68.94 beats/min | Standard Deviation 11.99 |
| Group ML | HR - M7a (Heart Rate in the Moment 7a) | 68.19 beats/min | Standard Deviation 7.73 |
| Group C | HR - M7a (Heart Rate in the Moment 7a) | 67.13 beats/min | Standard Deviation 8.85 |
p-value: 0.874695% CI: [51, 99]ANOVA
p-value: 0.874695% CI: [56, 82]ANOVA
p-value: 0.874695% CI: [54, 80]ANOVA
Secondary
HR - M7b (Heart Rate in the Moment 7b)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.
Time frame: This measure of heart rate was performed 30 minutes after the traqueal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M7b (Heart Rate in the Moment 7b) | 67.44 beats/min | Standard Deviation 10.95 |
| Group ML | HR - M7b (Heart Rate in the Moment 7b) | 68.38 beats/min | Standard Deviation 9.28 |
| Group C | HR - M7b (Heart Rate in the Moment 7b) | 64.00 beats/min | Standard Deviation 8.23 |
p-value: 0.419595% CI: [47, 92]ANOVA
p-value: 0.419595% CI: [53, 80]ANOVA
p-value: 0.419595% CI: [52, 80]ANOVA
Secondary
HR - M7c (Heart Rate in the Moment 7c)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.
Time frame: This measure of heart rate was performed 45 minutes after the traqueal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M7c (Heart Rate in the Moment 7c) | 65.75 beats/min | Standard Deviation 11.52 |
| Group ML | HR - M7c (Heart Rate in the Moment 7c) | 65.75 beats/min | Standard Deviation 10.19 |
| Group C | HR - M7c (Heart Rate in the Moment 7c) | 62.33 beats/min | Standard Deviation 9.26 |
p-value: 0.579695% CI: [47, 93]ANOVA
p-value: 0.579695% CI: [48, 79]ANOVA
p-value: 0.579695% CI: [50, 79]ANOVA
Secondary
HR - M7d (Heart Rate in the Moment 7d)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.
Time frame: This measure of heart rate was performed 60 minutes after the traqueal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | HR - M7d (Heart Rate in the Moment 7d) | 66.19 beats/min | Standard Deviation 12.82 |
| Group ML | HR - M7d (Heart Rate in the Moment 7d) | 65.31 beats/min | Standard Deviation 10.87 |
| Group C | HR - M7d (Heart Rate in the Moment 7d) | 61.93 beats/min | Standard Deviation 9 |
p-value: 0.535195% CI: [45, 92]ANOVA
p-value: 0.535195% CI: [47, 82]ANOVA
p-value: 0.535195% CI: [51, 79]ANOVA
Secondary
HR - M7e (Heart Rate in the Moment 7e)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.
Time frame: This measure of heart rate was performed 75 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | HR - M7e (Heart Rate in the Moment 7e) | 66.50 beats/min |
| Group ML | HR - M7e (Heart Rate in the Moment 7e) | 63.00 beats/min |
| Group C | HR - M7e (Heart Rate in the Moment 7e) | 58.00 beats/min |
p-value: 0.498895% CI: [42, 92]Kruskal-Wallis
p-value: 0.498895% CI: [50, 85]Kruskal-Wallis
p-value: 0.498895% CI: [51, 80]Kruskal-Wallis
Secondary
HR - M7f (Heart Rate in the Moment 7f)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.
Time frame: This measure of heart rate was performed 90 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | HR - M7f (Heart Rate in the Moment 7f) | 66.00 beats/min |
| Group ML | HR - M7f (Heart Rate in the Moment 7f) | 61.00 beats/min |
| Group C | HR - M7f (Heart Rate in the Moment 7f) | 61.00 beats/min |
p-value: 0.772395% CI: [43, 89]Kruskal-Wallis
p-value: 0.772395% CI: [51, 82]Kruskal-Wallis
p-value: 0.772395% CI: [50, 78]Kruskal-Wallis
Secondary
MAP - M1 (Mean Arterial Pressure in the Moment 1)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.
Time frame: This measure of average blood pressure was performed when the patient arrived in the operating room
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | MAP - M1 (Mean Arterial Pressure in the Moment 1) | 94.63 mmHg | Standard Deviation 10.18 |
| Group ML | MAP - M1 (Mean Arterial Pressure in the Moment 1) | 88.75 mmHg | Standard Deviation 10.05 |
| Group C | MAP - M1 (Mean Arterial Pressure in the Moment 1) | 100.10 mmHg | Standard Deviation 16.62 |
p-value: 0.052795% CI: [70, 112]ANOVA
p-value: 0.052795% CI: [65, 104]ANOVA
p-value: 0.052795% CI: [70, 140]ANOVA
Secondary
MAP - M2 (Mean Arterial Pressure in the Moment 2)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.
Time frame: This measure of average blood pressure was performed immediately before induction of anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | MAP - M2 (Mean Arterial Pressure in the Moment 2) | 87.63 mmHg | Standard Deviation 12.1 |
| Group ML | MAP - M2 (Mean Arterial Pressure in the Moment 2) | 84.69 mmHg | Standard Deviation 11.38 |
| Group C | MAP - M2 (Mean Arterial Pressure in the Moment 2) | 92.47 mmHg | Standard Deviation 12.3 |
p-value: 0.199695% CI: [60, 110]ANOVA
p-value: 0.199695% CI: [67, 109]ANOVA
p-value: 0.199695% CI: [73, 112]ANOVA
Secondary
MAP - M3 (Mean Arterial Pressure in the Moment 3)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.
Time frame: This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | MAP - M3 (Mean Arterial Pressure in the Moment 3) | 75.88 mmHg | Standard Deviation 11.95 |
| Group ML | MAP - M3 (Mean Arterial Pressure in the Moment 3) | 73.88 mmHg | Standard Deviation 9.8 |
| Group C | MAP - M3 (Mean Arterial Pressure in the Moment 3) | 76.73 mmHg | Standard Deviation 7.48 |
p-value: 0.714595% CI: [58, 107]ANOVA
p-value: 0.714595% CI: [59, 97]ANOVA
p-value: 0.714595% CI: [58, 86]ANOVA
Secondary
MAP - M4 (Mean Arterial Pressure in the Moment 4)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.
Time frame: This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M4 (Mean Arterial Pressure in the Moment 4) | 69.00 mmHg |
| Group ML | MAP - M4 (Mean Arterial Pressure in the Moment 4) | 63.00 mmHg |
| Group C | MAP - M4 (Mean Arterial Pressure in the Moment 4) | 74.00 mmHg |
p-value: 0.11395% CI: [57, 96]Kruskal-Wallis
p-value: 0.11395% CI: [55, 84]Kruskal-Wallis
p-value: 0.11395% CI: [59, 83]Kruskal-Wallis
Secondary
MAP - M5 (Mean Arterial Pressure in the Moment 5)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.
Time frame: This measure of average blood pressure was performed immediately before the tracheal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M5 (Mean Arterial Pressure in the Moment 5) | 62.50 mmHg |
| Group ML | MAP - M5 (Mean Arterial Pressure in the Moment 5) | 61.50 mmHg |
| Group C | MAP - M5 (Mean Arterial Pressure in the Moment 5) | 67.00 mmHg |
p-value: 0.073195% CI: [58, 98]Kruskal-Wallis
p-value: 0.073195% CI: [55, 74]Kruskal-Wallis
p-value: 0.073195% CI: [56, 85]Kruskal-Wallis
Secondary
MAP - M6 (Mean Arterial Pressure in the Moment 6)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.
Time frame: This measure of average blood pressure was performed one minute after the tracheal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M6 (Mean Arterial Pressure in the Moment 6) | 64.50 mmHg |
| Group ML | MAP - M6 (Mean Arterial Pressure in the Moment 6) | 64.00 mmHg |
| Group C | MAP - M6 (Mean Arterial Pressure in the Moment 6) | 69.00 mmHg |
p-value: 0.100295% CI: [60, 85]Kruskal-Wallis
p-value: 0.100295% CI: [56, 74]Kruskal-Wallis
p-value: 0.100295% CI: [60, 90]Kruskal-Wallis
Secondary
MAP - M7a (Mean Arterial Pressure in the Moment 7a)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.
Time frame: This measure of average blood pressure was performed 15 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M7a (Mean Arterial Pressure in the Moment 7a) | 66.00 mmHg |
| Group ML | MAP - M7a (Mean Arterial Pressure in the Moment 7a) | 61.50 mmHg |
| Group C | MAP - M7a (Mean Arterial Pressure in the Moment 7a) | 69.00 mmHg |
p-value: 0.093795% CI: [58, 80]Kruskal-Wallis
p-value: 0.093795% CI: [56, 90]Kruskal-Wallis
p-value: 0.093795% CI: [58, 87]Kruskal-Wallis
Secondary
MAP - M7b (Mean Arterial Pressure in the Moment 7b)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.
Time frame: This measure of average blood pressure was performed 30 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M7b (Mean Arterial Pressure in the Moment 7b) | 66.50 mmHg |
| Group ML | MAP - M7b (Mean Arterial Pressure in the Moment 7b) | 63.50 mmHg |
| Group C | MAP - M7b (Mean Arterial Pressure in the Moment 7b) | 68.00 mmHg |
p-value: 0.140695% CI: [60, 88]Kruskal-Wallis
p-value: 0.140695% CI: [55, 86]Kruskal-Wallis
p-value: 0.140695% CI: [55, 84]Kruskal-Wallis
Secondary
MAP - M7c (Mean Arterial Pressure in the Moment 7c)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.
Time frame: This measure of average blood pressure was performed 45 minutes after the traqueal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group M | MAP - M7c (Mean Arterial Pressure in the Moment 7c) | 69.25 mmHg | Standard Deviation 6.74 |
| Group ML | MAP - M7c (Mean Arterial Pressure in the Moment 7c) | 63.00 mmHg | Standard Deviation 7.62 |
| Group C | MAP - M7c (Mean Arterial Pressure in the Moment 7c) | 69.00 mmHg | Standard Deviation 7.56 |
p-value: 0.050495% CI: [60, 81]ANOVA
p-value: 0.050495% CI: [49, 79]ANOVA
p-value: 0.050495% CI: [58, 84]ANOVA
Secondary
MAP - M7d (Mean Arterial Pressure in the Moment 7d)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.
Time frame: This measure of average blood pressure was performed 60 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M7d (Mean Arterial Pressure in the Moment 7d) | 68.00 mmHg |
| Group ML | MAP - M7d (Mean Arterial Pressure in the Moment 7d) | 62.00 mmHg |
| Group C | MAP - M7d (Mean Arterial Pressure in the Moment 7d) | 66.00 mmHg |
p-value: 0.020595% CI: [60, 93]Kruskal-Wallis
p-value: 0.020595% CI: [54, 72]Kruskal-Wallis
p-value: 0.020595% CI: [59, 75]Kruskal-Wallis
Secondary
MAP - M7e (Mean Arterial Pressure in the Moment 7e)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.
Time frame: This measure of average blood pressure was performed 75 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M7e (Mean Arterial Pressure in the Moment 7e) | 68.00 mmHg |
| Group ML | MAP - M7e (Mean Arterial Pressure in the Moment 7e) | 66.00 mmHg |
| Group C | MAP - M7e (Mean Arterial Pressure in the Moment 7e) | 69.00 mmHg |
p-value: 0.300495% CI: [58, 86]Kruskal-Wallis
p-value: 0.300495% CI: [56, 78]Kruskal-Wallis
p-value: 0.300495% CI: [62, 81]Kruskal-Wallis
Secondary
MAP - M7f (Mean Arterial Pressure in the Moment 7f)
In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.
Time frame: This measure of average blood pressure was performed 90 minutes after the traqueal intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group M | MAP - M7f (Mean Arterial Pressure in the Moment 7f) | 64.00 mmHg |
| Group ML | MAP - M7f (Mean Arterial Pressure in the Moment 7f) | 64.50 mmHg |
| Group C | MAP - M7f (Mean Arterial Pressure in the Moment 7f) | 72.00 mmHg |
p-value: 0.017895% CI: [60, 84]Kruskal-Wallis
p-value: 0.017895% CI: [51, 75]Kruskal-Wallis
p-value: 0.017895% CI: [61, 91]Kruskal-Wallis