Surgical Conditions
Conditions
Brief summary
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.
Interventions
DRUGRocuronium
Sponsors
Merck Sharp & Dohme LLC
Medical Center Haaglanden
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA I-III * BMI \> 34 kg/m2 * Elective bariatric surgery.
Exclusion criteria
* Known or suspected neuromuscular disorders impairing neuromuscular function * Allergies to muscle relaxants, anesthetics or narcotics * A(family) history of malignant hyperthermia * Women who are or may be pregnant or are currently breast feeding * Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output \< 0.5 ml/kg/h for at least 6 h.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Rating | intraoperative | During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation | intraoperative | The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation). |
| Pain | postoperative, for up to 2 hours | pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported. |
| Respiration | 2 hours postoperative | Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported. |
| Mean Arterial Blood Pressure | 2 hours postoperative | Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate Neuromuscular Block rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches
Rocuronium | 50 |
| Deep Neuromuscular Block rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Rocuronium | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Logistic reasons | 3 | 6 |
Baseline characteristics
| Characteristic | Moderate Neuromuscular Block | Deep Neuromuscular Block | Total |
|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 10.6 | 47.2 years STANDARD_DEVIATION 11.1 | 47.1 years STANDARD_DEVIATION 10.9 |
| Gender Female | 41 Participants | 39 Participants | 80 Participants |
| Gender Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Surgical Rating
During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported.
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Neuromuscular Block | Surgical Rating | 4.2 units on a scale | Standard Deviation 0.7 |
| Deep Neuromuscular Block | Surgical Rating | 4.8 units on a scale | Standard Deviation 0.2 |
p-value: 0.001Mixed Models Analysis
Secondary
Extubation
The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).
Time frame: intraoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Moderate Neuromuscular Block | Extubation | 3 minutes |
| Deep Neuromuscular Block | Extubation | 3 minutes |
p-value: >0.05t-test, 2 sided
Secondary
Mean Arterial Blood Pressure
Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported.
Time frame: 2 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Neuromuscular Block | Mean Arterial Blood Pressure | 98 millimeters of mercury | Standard Deviation 13 |
| Deep Neuromuscular Block | Mean Arterial Blood Pressure | 101 millimeters of mercury | Standard Deviation 15 |
p-value: >0.05t-test, 2 sided
Secondary
Pain
pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.
Time frame: postoperative, for up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Neuromuscular Block | Pain | 4.4 units on a scale | Standard Deviation 1.4 |
| Deep Neuromuscular Block | Pain | 3.9 units on a scale | Standard Deviation 1.4 |
p-value: 0.04t-test, 2 sided
Secondary
Respiration
Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported.
Time frame: 2 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate Neuromuscular Block | Respiration | 12.7 breaths per minute | Standard Deviation 0.7 |
| Deep Neuromuscular Block | Respiration | 12.6 breaths per minute | Standard Deviation 1.1 |
p-value: >0.05t-test, 2 sided