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Clinical Trials/NCT00392158
NCT00392158CompletedPhase 4

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

Hopital Foch6 sites in 1 country240 target enrollmentStarted: February 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
240
Locations
6
Primary Endpoint
Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •surgery under general anesthesia using relaxant agent,
  • •surgery lasting more than one hour

Exclusion Criteria

  • •pregnant women,
  • •indication for rapid sequence induction,
  • •anticipation of difficult intubation,
  • •allergy to propofol or remifentanil,
  • •neurological or muscular disorder,
  • •combination of general anesthesia and of regional anesthesia,
  • •emergency surgery.

Outcomes

Primary Outcomes

Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

Secondary Outcomes

  • number of episodes of hemodynamic anomalies having required a treatment
  • intraoperative volume loading and transfusion
  • consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
  • number of modifications of target of propofol and remifentanil
  • extubation time, explicit memorisation
  • dysfunctions of each system

Investigators

Sponsor Class
Other

Study Sites (6)

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