Closed-loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation

Liver Transplantation Clinical Trial

— Drone-TH  

Official title:

Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00477347
• Other study ID #: 2006/37
• Status: Terminated
• Phase: Phase 4
• First received: May 21, 2007
• Last updated: September 22, 2016
• Start date: May 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation

Description:

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We hypothesized that BIS can also indicate the adequacy of analgesia. Therefore we built a combined closed-loop anesthesia system using BIS as control variable and two proportional-differential control algorithms, a propofol and a remifentanil target-controlled infusion system. The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective, randomized study.

Elimination of anesthetic agents, propofol in particular, is strongly reduced during liver transplantation. Closed-loop anesthesia could provide adequacy for requirements in respect to the various phases of transplantation. 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 range recommended by the manufacturer during anesthesia. We expect the combined closed-loop anesthesia system group to do better: i.e. diminished consumption of propofol (primary outcome measure).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• liver transplantation

Exclusion Criteria:

• pregnant women

• allergy to propofol or remifentanil,

• neurological or muscular disorder,

• liver encephalopathy,

• patients taking psychotropic agents

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Closed loop administration
intraoperative closed loop administration of propofol and remifentanil
• Manual administration
intraoperative manual administration of propofol and remifentanil

Locations

Country	Name	City	State
France	Dept of Anesthesia and Intensive Care, Hôpital Beaujon	Clichy
France	Dept of Anesthesia and Intensive Care, Hôpital H. Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of propofol during anesthesia maintenance		during anesthesia maintenance	No
Secondary	- consumption of remifentanil - target modifications - hemodynamic events - volume loading and transfusion - extubation time, explicit memorization - time passed at BIS between 40 and 60 - MDAPE, wobble - global score - dysfunction of each system.		during anesthesia maintenance	No