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Clinical Trials/NCT00393003
NCT00393003
Completed
Phase 4

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

Hopital Foch2 sites in 1 country32 target enrollmentSeptember 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Postoperative Sedation
Sponsor
Hopital Foch
Enrollment
32
Locations
2
Primary Endpoint
Global score (calculated parameter which depicts the performance of the system)
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
April 2007
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnant women
  • Neurological or muscular disorder

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.

Study Sites (2)

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