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
PHASE3
67 participants
INTERVENTIONAL
2013-07-31
2015-10-07
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
DOUBLE
Study Groups
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Ketamine
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Ketamine (bolus dose of Ketamine (0.15 mg.kg-1) followed by an infusion of Ketamine (0.15 mg.kg-1 h-1) until the end of anesthesia)
Ketamine
Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo (NaCl 9/00 (same volume as in the Ketamine group)
Placebo
Interventions
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Ketamine
Placebo
Eligibility Criteria
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Inclusion Criteria
* scheduled for a surgical procedure lasting more than 2 hours under general anesthesia
Exclusion Criteria
* chronic pain
* simultaneous general and loco-regional anesthesia
* contra-indication to to nonsteroidal anti-inflammatory drug
* contra-indication to Ketamine
* contra-indication to propofol, to remifentanil, to morphine
* history of central nervous system disease
* patients receiving a psychotropic treatment
* patients with a pace-maker
18 Years
65 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
Locations
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Hopital Foch
Suresnes, Hauts de Seine, France
Clinique Fontaine les Dijons
Fontaine-lès-Dijon, , France
Countries
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Other Identifiers
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2012-003001-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2012/26
Identifier Type: -
Identifier Source: org_study_id
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