Clinical Trials Directory

Trials / Completed

CompletedNCT00571181

Automated Anesthesia During Bronchoscopy

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

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

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.

Conditions

Interventions

TypeNameDescription
DEVICEClosed-loop systemAutomatic delivery of propofol and remifentanil
DEVICETCI (Infusion Toolbox)TCI administration of propofol and remifentanil

Timeline

Start date
2007-12-01
Primary completion
2008-09-01
Completion
2008-09-01
First posted
2007-12-11
Last updated
2016-09-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00571181. Inclusion in this directory is not an endorsement.