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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hopital Foch
- 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
Intervention: Closed-loop system (Device)
2
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)
