Influence of Muscle Relaxation on a Closed-loop Anesthesia System

Phase 3

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: muscle relaxant; Drug: normal saline

• Registration Number: NCT00886418
• Lead Sponsor: Hopital Foch

Brief Summary

Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-19
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Study Start: 2009-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• patients scheduled for a surgical procedure which not require a myorelaxation

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Exclusion Criteria

• age less than 18 years,
• ASA III and above,
• pregnant woman
• combined general and regional anesthesia,
• history of prolonged myorelaxation due to a decrease in cholinesterase,
• patient with a known lack in cholinesterase,
• history of cerebral or psychiatric central,
• allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
• known hypersensitivity to remifentanil or to an other derivative of fentanyl,
• presence of a pacemaker,
• psychotropic or agonist-antagonist morphine treatment,
• planned post-operative sedation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	muscle relaxant	Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia.
2	normal saline	Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia.

Primary Outcome Measures

Name	Time	Method
propofol dose	one hour anesthesia

Secondary Outcome Measures

Name	Time	Method
intraoperative awareness	postoperative day 1 or 2
number of patients' movements	one hour anesthesia
number of automatic modifications of the propofol and remifentanil concentrations	one hour anesthesia
time to wake up	end of anesthesia
number of hemodynamic abnormalities requiring treatment	one hour anesthesia
performance of the closed-loop system	one hour anesthesia
remifentanil dose	one hour anesthesia

Trial Locations

Locations (3)

Hôpital Foch; 🇫🇷 Suresnes, France

Institut Paoli-Calmette; 🇫🇷 Marseille, France

CHU Besançon; 🇫🇷 Besançon, France