Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy

NCT ID: NCT00391885

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-04-30

Brief Summary

This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controller.

Detailed Description

Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery.

Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE. We hypothesized that SE can be used as the control variable. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain SE between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop anesthesia system group to do similar or better.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Closed-loop anesthesia system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists physical status 1-3,
• surgery under general anesthesia using relaxant agent,
• surgery lasting more than one hour

Exclusion Criteria

• pregnant women,
• indication for rapid sequence induction,
• anticipation of difficult intubation,
• allergy to propofol or remifentanil,
• neurological or muscular disorder,
• combination of general anesthesia and of regional anesthesia,
• emergency surgery

• 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

Marc Fischler, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

Dept of Anesthesia and Intensive Care, Hôpital Beaujon

Clichy, , France

Dept of Anesthesiology, Hôpital Foch

Suresnes, , France

Countries

France

References

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

Reference Type: BACKGROUND

PMID: 16571963 (View on PubMed)

Other Identifiers

Foch-4

Identifier Type: -

Identifier Source: org_study_id