Clinical trial NCT00393003: Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index
Official title: Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Sedation
Keywords: Anesthesia
Sedation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2006-10-26
Enrollment: 32
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: This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

Detailed description: The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built 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. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. 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 system group to do similar or better.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-3
* Abdominal aorta surgery

Exclusion Criteria:

* Pregnant women
* Neurological or muscular disorder

Primary outcomes:
measure: Global score (calculated parameter which depicts the performance of the system)
Secondary outcomes:
measure: Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation.
Other outcomes:
Locations:
city: Paris
country: France
facility: Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière, 75013 Paris, France
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.