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Completed

NCT Number: NCT01828385

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Federal de Bonsucesso

Rio de Janeiro, 21041-030, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

Magnesium sulfate + rocuronium + sugammadex

Saline

Drug

Saline + rocuronium + sugammadex

Primary outcomes

  1. Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate

    Time frame: 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 outcomes

  1. Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Hospital Federal de Bonsucesso

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2013
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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