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Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium

Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium: Random and Double-blind Clinical Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02989272
Enrollment
60
Registered
2016-12-12
Start date
2016-12-31
Completion date
2017-12-31
Last updated
2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnesium Sulfate, Neuromuscular Blockade, Rocuronium, Deep Neuromuscular Blockade

Brief summary

It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is that pre-treatment with magnesium sulfate, due to its action at the neuromuscular junction,potentiate the duration of deep neuromuscular block following rocuronium curarization in patients undergoing general anesthesia. Magnesium sulphate has gained prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of neuromuscular blockade among other functions. The deep neuromuscular block is defined as the one obtained by the absence of response to the sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic counts . There is no literature description of the role of magnesium sulphate in Duration of the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium This study is justified because extending the clinical duration of neuromuscular blockers may translate into gains for surgeries that require deep and long-lasting muscle relaxation as in laparoscopic and robotic surgeries. This block allows lower inflation pressures of the pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and cardiorespiratory repercussion for the patient

Detailed description

Patients will be selected from those who use the General Surgery Service of the Federal Hospital of Bonsucesso for medical indication or own will, obeying the inclusion and exclusion criteria. After signing the informed consent, they will be evaluated clinically and laboratorially, according to the routine of preoperative exams and pre-anesthetic outpatient evaluation. Patients will be allocated to one of two groups: control group (30 patients), who will receive pretreatment by venous infusion of saline solution; And magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg according to the random number sequence generated electronically through the QuickCalcs program (GraphPad Software, San Diego, CA) Because it is a double-blind study, both the researcher and the patient will not know which of the groups will be studied. The principal investigator will be responsible for the delivery of sealed envelope containing the sequence of cases allocated in each of the groups to another anesthesiologist who will prepare the solution (saline or magnesium sulphate) and will record in a specific file in which group the volunteer was Allocated. Again the envelope will be sealed for tabulation later, without the knowledge of the researcher. The same principal investigator will be in charge of the measurement and recording of the data collected.

Interventions

magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg

saline group (30 patients) who will receive pretreatment by saline solution

Sponsors

Hospital Federal de Bonsucesso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Physical State American Society of Anesthesiologists (ASA) I, II and III; Body mass index between 18.5 and 24.9;Otorhinolaryngological surgeries

Exclusion criteria

Refusal to participate in the study; * Pregnancy or suspected pregnancy; Neuromuscular diseases, renal or hepatic impairment; * Hepatic dysfunction; * History or predictors of difficult airway; Hypermagnesemia (Mg\> 2.5 mEq / L); * Hypomagnesemia (Mg \<1.7 mEq / L); * Use of furosemide, aminoglycosides, aminophylline, azathioprine; Cyclophosphamide, anti-inflammatories and magnesium; * Allergy to the drugs used in the study; * Participants from other clinical studies. * Emergency surgeries.

Design outcomes

Primary

MeasureTime frameDescription
duration of deep neuromuscular blockperioperativeTo determine the duration of deep neuromuscular block following a single dose of rocuronium

Secondary

MeasureTime frameDescription
residual neuromuscular block in PACU6hEvaluate the eventual occurrence of residual neuromuscular block in PACU
evolution of the height of T1perioperative- until 48hRecord the evolution of the height of T1
onset time and recovery time of rocuroniumperioperative- until 48hto determine the pharmacodynamic parameters of rocuronium
episodes of nausea and vomiting and treatment of surgery to dischargeperioperative- until 48hAssess the frequency of individual episodes of nausea and vomiting and treatment during the period from the end of surgery to discharge
frequency of pain or unpleasant sensationperioperative- until 48hEvaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions
postoperative painperioperative- until 48hEvaluate postoperative pain with questionnaire and visual scale of pain

Countries

Brazil

Contacts

Primary ContactAngelo Jorge Q R Micuci, doctor anesthesiology
angelojorgemicuci@gmail.com21997828668
Backup ContactIsmar L Cavalcanti, master
ismarcavalcanti@gmail.com999822993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026