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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
  Purpose

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.


Condition Intervention Phase
General Anesthesia
 Drug: remifentanil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • amount of remifentanil delivered by the closed-loop system [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • amount of propofol delivered by the closed-loop system [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
general anesthesia and thoracic epidural administration of saline
 Drug: remifentanil
dosage
Other Name: Remifentanil: Ultiva
Active Comparator: 2
general anesthesia and thoracic epidural administration of chirocaine
 Drug: remifentanil
dosage
Other Name: Remifentanil: Ultiva

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627081

Locations
France
Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch, 92150 Suresnes, France
  More Information

Publications:
Liu N, Hamada S, Chazot T, Landais A, Fischler M. Propofol and Remifentanil Guided Solely by the Bispectral Index: Closed-Loop Versus Manual Control. Anesthesiology ASA A854, 2006

Responsible Party: M. Fischler, principal investigator, Hopital Foch, 92150, Suresnes, France
ClinicalTrials.gov Identifier: NCT00627081     History of Changes
Other Study ID Numbers: 2007/11
Study First Received: February 20, 2008
Last Updated: January 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 23, 2013