Influence of Muscle Relaxation on a Closed-loop Anesthesia System

NCT ID: NCT00886418

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2015-02-28

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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.

Group Type: ACTIVE_COMPARATOR

muscle relaxant

Intervention Type: DRUG

muscle relaxant administration throughout anesthesia

2

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.

Group Type: EXPERIMENTAL

normal saline

Intervention Type: DRUG

no muscle relaxant throughout anesthesia (normal saline infused as a placebo)

Interventions

muscle relaxant

muscle relaxant administration throughout anesthesia

Intervention Type: DRUG

normal saline

no muscle relaxant throughout anesthesia (normal saline infused as a placebo)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Fischler, MD

Role: STUDY_CHAIR

Hôpital Foch

Locations

CHU Besançon

Besançon, , France

Institut Paoli-Calmette

Marseille, , France

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

2008/28

Identifier Type: -

Identifier Source: org_study_id