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

Automated Anesthesia During Bronchoscopy

Sponsors

Lead sponsor: Hopital Foch

Source Hopital Foch
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.

Overall Status Completed
Start Date December 2007
Completion Date September 2008
Primary Completion Date September 2008
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of time with BIS in the desired range During the procedure
Secondary Outcome
Measure Time Frame
consumption of propofol and remifentanil during the procedure
extubation time during the procedure
explicit memorisation postoperative day 2
Enrollment 66
Condition
Intervention

Intervention type: Device

Intervention name: Closed-loop system

Description: Automatic delivery of propofol and remifentanil

Arm group label: 1

Intervention type: Device

Intervention name: TCI (Infusion Toolbox)

Description: TCI administration of propofol and remifentanil

Arm group label: 2

Eligibility

Criteria:

Inclusion Criteria:

- patients undergoing rigid bronchoscopy under general anesthesia

Exclusion Criteria:

- pregnant women

- allergy to propofol or remifentanil

- neurological disorder

- psychotrop treatment

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Marc Fischler, MD Study Chair Hopital Foch
Location
facility Service d'Anesthésie, Hôpital Foch
Location Countries

France

Verification Date

September 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Experimental

Arm group label: 2

Arm group type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov