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

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ClinicalTrials.gov Identifier: NCT00627081
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

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 or disease Intervention/treatment Phase
General Anesthesia Drug: remifentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy
Study Start Date : February 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. amount of remifentanil delivered by the closed-loop system [ Time Frame: end of anesthesia ]

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


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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:

  • 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.

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): NCT00627081


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

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00627081     History of Changes
Other Study ID Numbers: 2007/11
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

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