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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Magnesium Sulfate, Neuromuscular Blockade, Rocuronium, Deep Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sulfate, Magnesium
* Other: saline group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline group<br>Control group (30 patients), who will receive Treatment by venous infusion of saline solution | Other: saline group<br>* saline group (30 patients) who will receive pretreatment by saline solution<br>|
| Experimental: Sulfate group<br>magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg | Drug: Sulfate, Magnesium<br>* magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of deep neuromuscular block | To determine the duration of deep neuromuscular block following a single dose of rocuronium | perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset time and recovery time of rocuronium | to determine the pharmacodynamic parameters of rocuronium | perioperative- until 48h | 
| residual neuromuscular block in PACU | Evaluate the eventual occurrence of residual neuromuscular block in PACU | 6h | 
| evolution of the height of T1 | Record the evolution of the height of T1 | perioperative- until 48h | 
| postoperative pain | Evaluate postoperative pain with questionnaire and visual scale of pain | perioperative- until 48h | 
| episodes of nausea and vomiting and treatment of surgery to discharge | Assess the frequency of individual episodes of nausea and vomiting and treatment during the period from the end of surgery to discharge | perioperative- until 48h | 
| frequency of pain or unpleasant sensation | Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions | perioperative- until 48h |