NCT01301261

Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Detailed description

Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied. Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium. Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

Conditions

• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
DRUG	sugammadex	Sugammadex 2 mg/kg when a two count of train of four appears
DRUG	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears
DRUG	Sugammadex 16mg/kg	Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-02-01
• First posted: 2011-02-23
• Last updated: 2012-06-19

Locations

1 site across 1 country: Greece