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Clinical Trials/NCT00571181
NCT00571181CompletedPhase 4

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

Hopital Foch1 site in 1 country66 target enrollmentStarted: December 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
Percentage of time with BIS in the desired range

Study Overview

Brief Summary

The purpose of this study is to compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during rigid bronchoscopy.

Detailed Description

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We have 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. A recent study has shown that such system is able to provide clinically adequate anesthesia. The aim of the present study is to assess the system during rigid bronchoscopy. 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

  • •patients undergoing rigid bronchoscopy under general anesthesia

Exclusion Criteria

  • •pregnant women
  • •allergy to propofol or remifentanil
  • •neurological disorder
  • •psychotrop treatment

Arms & Interventions

1

Experimental

Intervention: Closed-loop system (Device)

2

Active Comparator

Intervention: TCI (Infusion Toolbox) (Device)

Outcomes

Primary Outcomes

Percentage of time with BIS in the desired range

Time Frame: During the procedure

Secondary Outcomes

  • consumption of propofol and remifentanil(during the procedure)
  • extubation time(during the procedure)
  • explicit memorisation(postoperative day 2)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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