Comparison of Different Propofol Formulations With or Without Remifentanil
NCT ID: NCT01592162
Last Updated: 2016-11-03
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
PHASE4
409 participants
INTERVENTIONAL
2013-05-31
2014-11-30
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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propofol 1% (Astra-Zeneca) - remi 0
propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml
Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
propofol 1% (Astra-Zeneca) - remi 2
propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml
propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol 1% (Astra-Zeneca) - remi 4
propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml
propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
propofol 1% (Fresenius) - remi 0
propofol 1% (Fresenius) plus remifentanil 0 ng/ml
Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
propofol 1% (Fresenius) - remi 2
propofol 1% (Fresenius) plus remifentanil 2 ng/ml
Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol 1% (Fresenius) - remi 4
propofol 1% (Fresenius) plus remifentanil 4 ng/ml
Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
propofol 1% (B-Braun) - remi 0
propofol 1% (B-Braun) plus remifentanil 0 ng/ml
Propofol (B-Braun) and NaCl 0.9%
propofol administered by a closed-loop system and saline
propofol 1% (B-Braun) - remi 2
propofol 1% (B-Braun) plus remifentanil 2 ng/ml
Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol 1% (B-Braun) - remi 4
propofol 1% (B-Braun) plus remifentanil 4 ng/ml
Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
Interventions
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Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
Propofol (B-Braun) and NaCl 0.9%
propofol administered by a closed-loop system and saline
Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or breastfeeding
* Allergy to propofol, soya or peanuts,
* Allergy to remifentanil,
* History of central neurological disorder or brain injury,
* Patients receiving psychotropic drugs,
* Patient with a pacemaker
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
Hopital Foch
Locations
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CHU Besançon
Besançon, , France
Hopital Foch
Suresnes, Île-de-France Region, France
Countries
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Other Identifiers
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2011-002644-27
Identifier Type: OTHER
Identifier Source: secondary_id
2011/34
Identifier Type: -
Identifier Source: org_study_id