Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio .
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Magnesium Sulfate
- 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).
Intervention: Magnesium Sulfate (Drug)
Saline Solution
- 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.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio .
Time Frame: 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 Outcomes
- Record the evolution of the height of the first response (T1)(1 hour after the end of surgery)
- Record the possible occurrence of severe respiratory complications every 24 hours(72 hours max)
- Record the possible serious respiratory events in the post-anesthetic recovery room(1 hour after the end of surgery)
- Evaluate postoperative pain(72 hours)
- Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room(1 hour after the end of surgery)
Investigators
Paulo Alipio Germano Filho
MD, MSc
Universidade Federal do Rio de Janeiro