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

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: Magnesium Sulfate; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01828385

PAGF-01M

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Group Mg

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate

Group C

Active Comparator group

Description:

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

Treatment:

Drug: Saline