Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex

Study Overview
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Brief Summary
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The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.

Detailed Description
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Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents. Primary outcome: evaluate the effect of pretreatment with magnesium sulfate on the time reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular blockade (two answers to a train-of-four TOF) induced by rocuronium. Secondary outcome: evaluate severe respiratory events, the incidence of residual neuromuscular blockade in the post anesthesia recovery room and postoperative pain.

Official Title
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Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years ASA physical status 1 or 2 weight BMI 18.5-24.9 otorhinolaryngological surgeries Exclusion Criteria: major surgery associated with massive blood loss or fluid replacement any known allergy to magnesium sulphate or any other study drugs pregnant anatomical malformations expected to result in a difficult intubation; known or suspected neuromuscular disorders and/or significant hepatic or renal dysfunction administration of any medication known to interfere with neuromuscular blocking agents (such as anticonvulsants, aminoglycosides, calcium channel blockers and magnesium containing medications) hypomagnesemia, hypermagnesemia, hypocalcemia, hypercalcemia

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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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Mg<br>Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1 | Drug: Magnesium Sulfate<br>* Magnesium sulfate + rocuronium + sugammadex<br>|
| Active Comparator: Group C<br>Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1 | Drug: Saline<br>* Saline + rocuronium + sugammadex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate | When T1 reached 25%, a single bolus dose of sugammadex 2 mg.kg-1 was administered to facilitate the recovery. The times to reach a TOF ratio of 0.9 and T1 height value were measured. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room | Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacologic Actions, Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Molecular Mechanisms of Pharmacological Action, Neuromuscular block, antagonism