Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

NCT ID: NCT00627081

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

general anesthesia and thoracic epidural administration of saline

Group Type PLACEBO_COMPARATOR

remifentanil

Intervention Type DRUG

dosage

2

general anesthesia and thoracic epidural administration of chirocaine

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

dosage

Interventions

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remifentanil

dosage

Intervention Type DRUG

Other Intervention Names

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Remifentanil: Ultiva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hopital Foch, 92150 Suresnes, France

Locations

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Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

Reference Type BACKGROUND
PMID: 16571963 (View on PubMed)

Other Identifiers

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2007/11

Identifier Type: -

Identifier Source: org_study_id

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