Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

Study Overview
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Brief Summary
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The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1 ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by rocuronium.

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: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium. Secondary outcome: evaluate the occurrence of severe respiratory events, the incidence of residual neuromuscular block in the post-anesthetic recovery room, evolution of T1 high, and postoperative pain.

Official Title
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Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

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: ASA physical status 1 or 2 weight BMI 18.5-24.9 otorhinolaryngological surgeries Exclusion Criteria: refusal to participate in the study; pregnancy or suspected pregnancy; neuromuscular diseases, renal or hepatic impairment; hepatic dysfunction; story or predictors of difficult airway; hypermagnesemia (Mg> 2.5 mEq / L); hypomagnesemia (Mg <1.7 mEq / L); furosemide, aminoglycosides, aminophylline azathioprine; cyclophosphamide, anti-inflammatory and magnesium; allergy to drugs used in the study; participants from other clinical studies.

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 |
| --- | --- |
| Active Comparator: Magnesium Sulfate<br>After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) or reappearance of 2 twitches of the train of four (moderate neuromuscular block), 4 mg/kg (deep neuromuscular block) or 2 mg/kg (moderate neuromuscular block) of sugammadex are given intravenously. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution). | Drug: Magnesium Sulfate<br>* After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).<br>* Other names: magnesium sulphate;|
| Placebo Comparator: Saline Solution<br>After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) or reappearance of 2 twitches of the train of four (moderate neuromuscular block), 4 mg/kg (deep neuromuscular block) or 2 mg/kg (moderate neuromuscular block) of sugammadex are given intravenously. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously 100 mL saline solution over 10 minutes. | Drug: Saline<br>* After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).<br>* Other names: NaCl 0,9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio . | The T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.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. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record the possible serious respiratory events in the post-anesthetic recovery room | Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia). | 1 hour after the end of surgery | 
| Evaluate the occurrence of any residual neuromuscular block in the post anesthetic 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. | 1 hour after the end of surgery | 
| Record the evolution of the height of the first response (T1) | 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. | 1 hour after the end of surgery | 
| Record the possible occurrence of severe respiratory complications every 24 hours | Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia). | 72 hours max | 
| Evaluate postoperative pain | Use of visual analogue pain scale (0-10) questionnaire | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Neuromuscular block, antagonism