NCT00393003

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Sedation

Interventions

Type	Name	Description
DEVICE	Closed-loop anesthesia system

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-10-26
• Last updated: 2009-08-31

Locations

2 sites across 1 country: France