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

Phase 4

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Magnesium Sulfate; Drug: Saline

• Registration Number: NCT01828385
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-17
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Mg	Magnesium Sulfate	Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
Group C	Saline	Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1

Primary Outcome Measures

Name	Time	Method
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate	3 hours	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.

Secondary Outcome Measures

Name	Time	Method
Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room	4 hours	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