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Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393003
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : August 31, 2009
Sponsor:
Information provided by:
Hopital Foch

Tracking Information
First Submitted Date  ICMJE October 24, 2006
First Posted Date  ICMJE October 26, 2006
Last Update Posted Date August 31, 2009
Study Start Date  ICMJE September 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
Global score (calculated parameter which depicts the performance of the system)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index
Official Title  ICMJE Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Sedation
Intervention  ICMJE Device: Closed-loop anesthesia system
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 25, 2006)
32
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Neurological or muscular disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393003
Other Study ID Numbers  ICMJE Foch-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc Fischler, Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Morgan Le Guen, MD Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière, 75013 Paris, France
PRS Account Hopital Foch
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP