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