Completed

Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial

What is being tested

Magnesium Sulfate

+ Saline

Drug

Who is being recruted

From 18 to 65 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorUniversidade Federal do Rio de Janeiro

Last updated: January 21, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01828385

Principal SponsorUniversidade Federal do Rio de Janeiro

Last updated: January 21, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

ASA physical status 1 or 2

Age 18-65 years

otorhinolaryngological surgeries

weight BMI 18.5-24.9

7 exclusion criteria prevent from participating

administration of any medication known to interfere with neuromuscular blocking agents (such as anticonvulsants, aminoglycosides, calcium channel blockers and magnesium containing medications)

anatomical malformations expected to result in a difficult intubation

any known allergy to magnesium sulphate or any other study drugs

hypomagnesemia, hypermagnesemia, hypocalcemia, hypercalcemia

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital Federal de Bonsucesso

Rio de Janeiro, BrazilOpen Hospital Federal de Bonsucesso in Google Maps

CompletedOne Study Center