Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
- Registration Number
- NCT02932254
- Lead Sponsor
- Universidade Federal do Rio de Janeiro
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA physical status 1 or 2
- weight BMI 18.5-24.9
- otorhinolaryngological surgeries
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Solution Saline 1. After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. 2. 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. 3. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously 100 mL saline solution over 10 minutes. Magnesium Sulfate Magnesium Sulfate 1. After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. 2. 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. 3. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
- Primary Outcome Measures
Name Time Method Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio . 3 hours 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.
- Secondary Outcome Measures
Name Time Method Record the evolution of the height of the first response (T1) 1 hour after the end of surgery 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.
Record the possible occurrence of severe respiratory complications every 24 hours 72 hours max 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).
Record the possible serious respiratory events in the post-anesthetic recovery room 1 hour after the end of surgery 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).
Evaluate postoperative pain 72 hours Use of visual analogue pain scale (0-10) questionnaire
Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room 1 hour after the end of surgery 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.
Trial Locations
- Locations (1)
Hospital Federal de Bonsucesso
🇧🇷Rio de Janeiro, RJ, Brazil