Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

Not Applicable

• Conditions: Surgical Procedure, Unspecified
• Interventions: Drug: Sugammadex 4 mg/kg; Drug: Sugammadex 16mg/kg; Drug: sugammadex

• Registration Number: NCT01301261
• Lead Sponsor: University of Athens

Brief 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

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19
• Primary Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients ASA I-III scheduled for elective major surgery
• both sexes

Exclusion Criteria

• patients hypertensive
• treated with antihypertensive drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mg/kg of sugammadex	Sugammadex 4 mg/kg	4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears
Sugammadex 16 mg/kg	Sugammadex 16mg/kg	Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium
sugammadex 2 mg/kg	sugammadex	2 mg/kg of sugammadex are given when a response of two counts of train of four are present

Primary Outcome Measures

Name	Time	Method
Entropy	every three minutes

Secondary Outcome Measures

Name	Time	Method
hemodynamics	every three minutes

Trial Locations

Locations (1)

Department of Anesthesiology, Aretaieio Hospital; 🇬🇷 Athens, Greece