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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-02-28

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.

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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.

Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Mg

Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Magnesium sulfate + rocuronium + sugammadex

Group C

Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

Saline + rocuronium + sugammadex

Interventions

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Magnesium Sulfate

Magnesium sulfate + rocuronium + sugammadex

Intervention Type DRUG

Saline

Saline + rocuronium + sugammadex

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No