Influence of Dexmedetomidine on a Closed-Loop Anesthesia System
NCT ID: NCT00921284
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
PHASE3
66 participants
INTERVENTIONAL
2009-06-30
2011-07-31
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
TRIPLE
Study Groups
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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 dexmedetomidine group
dexmedetomidine
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine
dexmedetomidine
1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr
Interventions
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NaCl 9/00
Same volume as in the dexmedetomidine group
dexmedetomidine
1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient,
* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
* history of central nervous system disease,
* patients receiving a psychotropic treatment or an agonist-antagonist opiate,
* hypovolemic patients,
* patients receiving a cardio-vascular treatment,
* expected bleeding surgical procedure,
* simultaneous general and loco-regional anesthesia,
* severe hepatic insufficiency.
18 Years
MALE
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
Locations
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Hôpital Foch
Suresnes, , France
Countries
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Other Identifiers
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2008/41
Identifier Type: -
Identifier Source: org_study_id
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