Clinical trial NCT00391885: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy
Official title: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, General
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 60
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 study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controller.

Detailed description: Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery.

Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE. We hypothesized that SE can be used as the control variable. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. 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 SE 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:

* American Society of Anesthesiologists physical status 1-3,
* surgery under general anesthesia using relaxant agent,
* surgery lasting more than one hour

Exclusion Criteria:

* pregnant women,
* indication for rapid sequence induction,
* anticipation of difficult intubation,
* allergy to propofol or remifentanil,
* neurological or muscular disorder,
* combination of general anesthesia and of regional anesthesia,
* emergency surgery

Primary outcomes:
measure: Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)
Secondary outcomes:
measure: consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
measure: number of modifications of target of propofol and remifentanil
measure: number of episodes of hemodynamic anomalies having required a treatment
measure: intraoperative volume loading and transfusion
measure: extubation time, explicit memorisation
measure: dysfunctions of each system
Other outcomes:
Locations:
city: Clichy
country: France
facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon
city: Suresnes
country: France
facility: Dept of Anesthesiology, Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
affiliation: Hôpital Foch
name: Marc Fischler, 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.