Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex
|ClinicalTrials.gov Identifier: NCT01828385|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : January 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Blockade||Drug: Magnesium Sulfate Drug: Saline||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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
Saline + rocuronium + sugammadex
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828385
|Hospital Federal de Bonsucesso|
|Rio de Janeiro, RJ, Brazil, 21041-030|
|Principal Investigator:||Paulo A Germano Filho, MD||Hospital Federal de Bonsucesso|
|Study Director:||Núbia V Figueiredo, PhD||Universidade Federal do Rio de Janeiro|
|Study Director:||Ismar L Cavalcanti, PhD||Universidade Federal do Rio de Janeiro|