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

September 22, 2016 updated by: Hopital Foch

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
general anesthesia and thoracic epidural administration of saline
Drug: remifentanil
dosage
Other Names:
  • Remifentanil: Ultiva
Active Comparator: 2
general anesthesia and thoracic epidural administration of chirocaine
Drug: remifentanil
dosage
Other Names:
  • Remifentanil: Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of remifentanil delivered by the closed-loop system
Time Frame: end of anesthesia
end of anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
amount of propofol delivered by the closed-loop system
Time Frame: end of anesthesia
end of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Study Chair: Marc Fischler, MD, Hopital Foch, 92150 Suresnes, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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