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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828385
• Other study ID #: PAGF-01M
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2013
• Last updated: January 17, 2015
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2015
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Magnesium Sulfate
Magnesium sulfate + rocuronium + sugammadex
• Saline
Saline + rocuronium + sugammadex

Locations

Country	Name	City	State
Brazil	Hospital Federal de Bonsucesso	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Hospital Federal de Bonsucesso

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Herroeder S, Schönherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes