Clinical trial NCT00571181: Automated Anesthesia During Bronchoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, General
Keywords: Algorithms
Anesthesia, General/*methods
Anesthetics, Intravenous/*administration & dosage
Drug Delivery Systems/*methods/statistics & numerical data
Electroencephalography/drug effects/*methods/
Feasibility Studies
Propofol/*administration & dosage
Remifentanil/*administration & dosage
Bronchoscopy/*methods
Prospective Studies
Software
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing rigid bronchoscopy under general anesthesia

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of time with BIS in the desired range
timeFrame: During the procedure
Secondary outcomes:
measure: consumption of propofol and remifentanil
timeFrame: during the procedure
measure: extubation time
timeFrame: during the procedure
measure: explicit memorisation
timeFrame: postoperative day 2
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Service d'Anesthésie, Hôpital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.
citation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
citation: Liu N, Pruszkowski O, Leroy JE, Chazot T, Trillat B, Colchen A, Gonin F, Fischler M. Automatic administration of propofol and remifentanil guided by the bispectral index during rigid bronchoscopic procedures: a randomized trial. Can J Anaesth. 2013 Sep;60(9):881-7. doi: 10.1007/s12630-013-9986-7. Epub 2013 Jul 16.