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

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

The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: Magnesium Sulfate; Drug: Saline

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21041-030
      • Hospital Federal de Bonsucesso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Mg; Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1	Drug: Magnesium Sulfate; Magnesium sulfate + rocuronium + sugammadex
Active Comparator: Group C; Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1	Drug: Saline; Saline + rocuronium + sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate	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.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room	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.	4 hours

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Hospital Federal de Bonsucesso
• Investigators: Principal Investigator: Paulo A Germano Filho, MD, Hospital Federal de Bonsucesso; Study Director: Nubia V Figueiredo, PhD, Universidade Federal do Rio de Janeiro; Study Director: Ismar L Cavalcanti, PhD, Universidade Federal do Rio de Janeiro

Publications and helpful links

General Publications

• Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
• Sauer M, Stahn A, Soltesz S, Noeldge-Schomburg G, Mencke T. The influence of residual neuromuscular block on the incidence of critical respiratory events. A randomised, prospective, placebo-controlled trial. Eur J Anaesthesiol. 2011 Dec;28(12):842-8. doi: 10.1097/EJA.0b013e328345cd11.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 17, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Physiological Effects of Drugs; Magnesium; Pharmacologic Actions; Rocuronium; Molecular Mechanisms of Pharmacological Action; Sugammadex sodium; Neuromuscular block, antagonism
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: PAGF-01M