Influence of Muscle Relaxation on a Closed-loop Anesthesia System

Anesthesia, General Clinical Trial

— Drone-Curare  

Official title:

Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886418
• Other study ID #: 2008/28
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2009
• Last updated: September 22, 2016
• Start date: December 2009
• Est. completion date: February 2015

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• muscle relaxant
muscle relaxant administration throughout anesthesia
• normal saline
no muscle relaxant throughout anesthesia (normal saline infused as a placebo)

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	Institut Paoli-Calmette	Marseille
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	propofol dose		one hour anesthesia	No
Secondary	remifentanil dose		one hour anesthesia	No
Secondary	number of automatic modifications of the propofol and remifentanil concentrations		one hour anesthesia	No
Secondary	number of patients' movements		one hour anesthesia	No
Secondary	number of hemodynamic abnormalities requiring treatment		one hour anesthesia	No
Secondary	time to wake up		end of anesthesia	No
Secondary	intraoperative awareness		postoperative day 1 or 2	No
Secondary	performance of the closed-loop system		one hour anesthesia	No