Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia
NCT ID: NCT00627081
Last Updated: 2016-09-23
Study Results
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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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2008-02-29
2011-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
general anesthesia and thoracic epidural administration of saline
remifentanil
dosage
2
general anesthesia and thoracic epidural administration of chirocaine
remifentanil
dosage
Interventions
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remifentanil
dosage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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2007/11
Identifier Type: -
Identifier Source: org_study_id
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