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

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: February 20, 2008
Last updated: September 22, 2016
Last verified: September 2016

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

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 ]

Secondary Outcome Measures:
  • amount of propofol delivered by the closed-loop system [ Time Frame: end of anesthesia ]

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
Other Name: Remifentanil: Ultiva
Active Comparator: 2
general anesthesia and thoracic epidural administration of chirocaine
Drug: remifentanil
Other Name: Remifentanil: Ultiva


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

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.
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Please refer to this study by its identifier: NCT00627081

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

Responsible Party: Hopital Foch Identifier: NCT00627081     History of Changes
Other Study ID Numbers: 2007/11
Study First Received: February 20, 2008
Last Updated: September 22, 2016

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General processed this record on May 25, 2017