Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

Phase 4

Completed

• Conditions: Postoperative Sedation

• Registration Number: NCT00393003
• Lead Sponsor: Hopital Foch

Brief Summary

This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

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, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. 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 system group to do similar or better.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-28
• Last Update Posted: 2009-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• American Society of Anesthesiologists physical status 1-3
• Abdominal aorta surgery

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Exclusion Criteria

• Pregnant women
• Neurological or muscular disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global score (calculated parameter which depicts the performance of the system)

Secondary Outcome Measures

Name	Time	Method
Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation.

Trial Locations

Locations (2)

Hôpital Foch; 🇫🇷 Suresnes, France

Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière; 🇫🇷 Paris, France