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Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia (Drone-APDT)

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00627081
First received: February 20, 2008
Last updated: January 22, 2011
Last verified: January 2011
History of Changes

February 20, 2008
January 22, 2011
February 2008
December 2010   (final data collection date for primary outcome measure)
amount of remifentanil delivered by the closed-loop system [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00627081 on ClinicalTrials.gov Archive Site
amount of propofol delivered by the closed-loop system [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia
Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy

The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic surgery with a demonstrated benefit on the risk of postoperative respiratory complications.

The objective of the study is to analyze the influence of thoracic epidural administration of chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil), these drugs being administrated using a closed-loop system with the Bispectral Index as the controller.

Two groups of patients are compared:

  • one group will receive general anesthesia and thoracic epidural administration of saline. Chirocaine will be administered before patient's awakening,
  • one group will receive general anesthesia and thoracic epidural administration of chirocaine (5 mg/ml).

In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both groups.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
General Anesthesia
Drug: remifentanil
dosage
Other Name: Remifentanil: Ultiva
  • Placebo Comparator: 1
    general anesthesia and thoracic epidural administration of saline
    Intervention: Drug: remifentanil
  • Active Comparator: 2
    general anesthesia and thoracic epidural administration of chirocaine
    Intervention: Drug: remifentanil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing a thoracotomy under general anesthesia and epidural anesthesia

Exclusion Criteria:

  • age lower than 18 years,
  • pregnant woman,
  • psychotropic treatment,
  • central neurological disorder or lesion cerebral,
  • allergy to propofol or to a muscle relaxant,
  • refusal or contra-indication of epidural anesthesia,
  • severe emphysema,
  • coronary disease,
  • treatment with a beta-blocker or a vasoactive drug.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00627081
2007/11
No
M. Fischler, principal investigator, Hopital Foch, 92150, Suresnes, France
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hopital Foch, 92150 Suresnes, France
Hopital Foch
January 2011

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