Clinical trial NCT01828385: Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex
Official title: Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: Physiological Effects of Drugs
Rocuronium
Sugammadex sodium
Magnesium
Molecular Mechanisms of Pharmacological Action
Neuromuscular block, antagonism
Pharmacologic Actions
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Hospital Federal de Bonsucesso
First posted: 2013-04-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate
timeFrame: 3 hours
Secondary outcomes:
measure: Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room
timeFrame: 4 hours
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal de Bonsucesso
state: RJ
Study officials:
affiliation: Hospital Federal de Bonsucesso
name: Paulo A Germano Filho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Núbia V Figueiredo, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal do Rio de Janeiro
name: Ismar L Cavalcanti, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.