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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TERMINATED
PHASE4
45 participants
INTERVENTIONAL
2008-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
closed-loop administration of propofol and remifentanil using bispectral index as the controller
Propofol
closed-loop administration using bispectral index as the controller
remifentanil
closed-loop administration using bispectral index as the controller
2
manual administration of propofol and remifentanil according to bispectral index values
Propofol
manual administration according bispectral index values
Remifentanil
manual administration according bispectral index values
Interventions
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Propofol
closed-loop administration using bispectral index as the controller
remifentanil
closed-loop administration using bispectral index as the controller
Propofol
manual administration according bispectral index values
Remifentanil
manual administration according bispectral index values
Eligibility Criteria
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Inclusion Criteria
* general anesthesia scheduled to last more than one hour
* intraoperative hemorrhage planned to be less than 15% of the blood volume
Exclusion Criteria
* Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
* History of a neurological or a psychiatric disorder, or central brain lesion,
* Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
* Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to remifentanil or to a derivate of fentanyl,
* Scheduled postoperative ventilation or sedation.
6 Years
16 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
Hôpital Foch, Suresnes, France
Locations
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Hôpital Necker Enfants
Paris, , France
Hôpital Foch
Suresnes, , France
Countries
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Other Identifiers
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2008/21
Identifier Type: -
Identifier Source: org_study_id
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