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

Anesthesia, General Clinical Trial

Official title:

Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391885
• Other study ID #: Foch-4
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2006
• Last updated: September 26, 2016
• Start date: September 2006
• Est. completion date: April 2007

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• Closed-loop anesthesia system

Locations

Country	Name	City	State
France	Dept of Anesthesia and Intensive Care, Hôpital Beaujon	Clichy
France	Dept of Anesthesiology, Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)
Secondary	consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
Secondary	number of modifications of target of propofol and remifentanil
Secondary	number of episodes of hemodynamic anomalies having required a treatment
Secondary	intraoperative volume loading and transfusion
Secondary	extubation time, explicit memorisation
Secondary	dysfunctions of each system