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
82 participants
INTERVENTIONAL
2011-01-31
2015-01-31
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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Lidocaine
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
Lidocaine
bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia.
start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine
Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Placebo
NaCl 9/00 (same volume as in the lidocaine group)
start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00
Interventions
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Lidocaine
bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia.
start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine
Placebo
NaCl 9/00 (same volume as in the lidocaine group)
start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* simultaneous general and loco-regional anesthesia
* allergy to NSAID
* treatment with verapamil, ketamine or gabapentin
* patients receiving an opioid preoperatively
* severe hepatic insufficiency
* contra-indication to lidocaine
* contra-indication to propofol or to remifentanil
* history of central nervous system disease
* patients receiving a psychotropic treatment
* patients with a pace-maker
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
Hôpital Foch
Locations
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Hopital Tenon
Paris, , France
Countries
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Other Identifiers
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2010-019979-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2010/18
Identifier Type: -
Identifier Source: org_study_id