Closed-Loop Anesthesia, Using Bispectral Index as the Control Variable, During Liver Transplantation (Drone-TH)
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Purpose
To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Transplantation |
Device: Closed loop administration Device: Manual administration |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-Loop, Using Bispectral Index as the Control Variable, During Liver Transplantation |
- consumption of propofol during anesthesia maintenance [ Time Frame: during anesthesia maintenance ] [ Designated as safety issue: No ]
- - 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. [ Time Frame: during anesthesia maintenance ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Manual administration
|
Device: Manual administration
intraoperative manual administration of propofol and remifentanil
Other Name: target controlled anesthesia
|
|
Experimental: 2
Closed-loop administration
|
Device: Closed loop administration
intraoperative closed loop administration of propofol and remifentanil
Other Name: closed-loop
|
Detailed 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- liver transplantation
Exclusion Criteria:
- pregnant women
- allergy to propofol or remifentanil,
- neurological or muscular disorder,
- liver encephalopathy,
- patients taking psychotropic agents
Contacts and Locations| France | |
| Dept of Anesthesia and Intensive Care, Hôpital Beaujon | |
| Clichy, France, 92110 | |
| Dept of Anesthesia and Intensive Care, Hôpital H. Mondor | |
| Créteil, France, 94000 | |
| Principal Investigator: | Marc Fischler, MD |
More Information
Publications:
| Responsible Party: | Marc Fischler, Hopital Foch |
| ClinicalTrials.gov Identifier: | NCT00477347 History of Changes |
| Other Study ID Numbers: | 2006/37 |
| Study First Received: | May 21, 2007 |
| Last Updated: | March 12, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hopital Foch:
|
Liver Transplantation Anesthesia, general Closed-loop |
Additional relevant MeSH terms:
|
Anesthetics Remifentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on June 17, 2013