Manual Administration of Propofol-Remifentanil Versus Dual Closed-Loop Using Bispectral Index as the Control Variable - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 24, 2006

Last Updated Date

April 21, 2007

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00392158 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
number of modifications of target of propofol and remifentanil
number of episodes of hemodynamic anomalies having required a treatment
intraoperative volume loading and transfusion
extubation time, explicit memorisation
dysfunctions of each system

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Manual Administration of Propofol-Remifentanil Versus Dual Closed-Loop Using Bispectral Index as the Control Variable

Official Title ^†

Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion

Brief Summary

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia

Detailed Description

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, a proportional–integral–differential control algorithm, and a propofol target-controlled infusion system as the control actuator.

Recent studies have shown that such system is able to provide clinically adequate anesthesia. We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system using BIS as the control variable, two proportional–integral–differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. 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 BIS 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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study

Condition ^†

Anesthesia, General

Intervention ^†

Device: Closed-loop anesthesia system

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

240

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00392158

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hopital Foch

Collaborators ^††

Investigators ^†

Principal Investigator:

Marc Fischler, MD

Hôpital Foch

Information Provided By

Hopital Foch

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.