Influence of Esmolol on a Closed-Loop Anesthesia System
NCT ID: NCT00922467
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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TERMINATED
PHASE3
15 participants
INTERVENTIONAL
2009-06-30
2011-12-31
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
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 esmolol group
Esmolol
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol
Esmolol
1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period
Interventions
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NaCl 9/00
Same volume as in the esmolol group
Esmolol
1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period
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,
* any other history of anaphylactic reaction,
* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
* hypersensibility to esmolol or to an excipient,
* history of central nervous system disease,
* patients receiving a psychotropic treatment or an agonist-antagonist opiate,
* hypovolemic patients,
* patients receiving a cardio-vascular treatment,
* patients with a pacemaker,
* expected bleeding more than 20% of the blood volume,
* simultaneous general and loco-regional anesthesia,
* patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
* patients with a heart rate less than 50/min and/or an arterial hypotension,
* neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.
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
Hôpital Foch
Locations
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Hôpital Foch
Suresnes, , France
Countries
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Other Identifiers
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2008/47
Identifier Type: -
Identifier Source: org_study_id
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