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

Postoperative Sedation Clinical Trial

Official title:

Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393003
• Other study ID #: Foch-1
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2006
• Last updated: August 28, 2009
• Start date: September 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2009
• 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 prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status 1-3

• Abdominal aorta surgery

Exclusion Criteria:

• Pregnant women

• Neurological or muscular disorder

Study Design

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

Related Conditions & MeSH terms

• Postoperative Sedation

Intervention

Device:
• Closed-loop anesthesia system

Locations

Country	Name	City	State
France	Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière	Paris
France	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)
Secondary	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.