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

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ClinicalTrials.gov Identifier: NCT00393003
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : August 31, 2009
Sponsor:
Information provided by:
Hopital Foch

Brief Summary:
This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

Condition or disease Intervention/treatment Phase
Postoperative Sedation Device: Closed-loop anesthesia system Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007



Primary Outcome Measures :
  1. Global score (calculated parameter which depicts the performance of the system)

Secondary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Neurological or muscular disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393003


Locations
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France
Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière
Paris, France, 75013
Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Morgan Le Guen, MD Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière, 75013 Paris, France
Publications:
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Responsible Party: Marc Fischler, Hopital Foch
ClinicalTrials.gov Identifier: NCT00393003    
Other Study ID Numbers: Foch-1
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: August 31, 2009
Last Verified: August 2009
Keywords provided by Hopital Foch:
Anesthesia
Sedation
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs