NCT00392158

Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable

Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia

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, a proportional-integral-differential control algorithm, and a propofol target-controlled infusion system as the control actuator. Recent studies have shown that such system is able to provide clinically adequate anesthesia. We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system 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. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. 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 anesthesia system group to do similar or better.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DEVICE	Closed-loop anesthesia system

Timeline

• Start date: 2006-02-01
• Completion: 2007-04-01
• First posted: 2006-10-25
• Last updated: 2016-09-26

Locations

6 sites across 1 country: France