- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592162
Comparison of Different Propofol Formulations With or Without Remifentanil (PropofolRemi)
November 2, 2016 updated by: Hopital Foch
Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction.
Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: Propofol (Astra-Zeneca), NaCl 0.9%
- Drug: propofol 1% (Astra-Zeneca) and remifentanil
- Drug: propofol 1% (Astra-Zeneca) and remifentanil
- Drug: Propofol (Astra-Zeneca) and remifentanil
- Drug: Propofol (Astra-Zeneca) and remifentanil
- Drug: Propofol (B-Braun) and NaCl 0.9%
- Drug: Propofol (B-Braun) and remifentanil
- Drug: Propofol (B-Braun) and remifentanil
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Besançon, France, 25034
- CHU Besançon
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Ile de France
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Suresnes, Ile de France, France, 92151
- Hôpital Foch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for an intravenous induction of anesthesia with propofol
Exclusion Criteria:
- Age under 18
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: propofol 1% (Astra-Zeneca) - remi 0
propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml
|
propofol administered by a closed-loop system and saline
|
Active Comparator: propofol 1% (Astra-Zeneca) - remi 2
propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml
|
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
|
Active Comparator: propofol 1% (Astra-Zeneca) - remi 4
propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml
|
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
|
Active Comparator: propofol 1% (Fresenius) - remi 0
propofol 1% (Fresenius) plus remifentanil 0 ng/ml
|
propofol administered by a closed-loop system and saline
|
Active Comparator: propofol 1% (Fresenius) - remi 2
propofol 1% (Fresenius) plus remifentanil 2 ng/ml
|
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
|
Active Comparator: propofol 1% (Fresenius) - remi 4
propofol 1% (Fresenius) plus remifentanil 4 ng/ml
|
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
|
Active Comparator: propofol 1% (B-Braun) - remi 0
propofol 1% (B-Braun) plus remifentanil 0 ng/ml
|
propofol administered by a closed-loop system and saline
|
Active Comparator: propofol 1% (B-Braun) - remi 2
propofol 1% (B-Braun) plus remifentanil 2 ng/ml
|
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
|
Active Comparator: propofol 1% (B-Braun) - remi 4
propofol 1% (B-Braun) plus remifentanil 4 ng/ml
|
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
Time Frame: one hour after anesthesia
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one hour after anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
calculated concentrations of propofol at the end of the anesthetic induction
Time Frame: one hour after anesthesia
|
one hour after anesthesia
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pain at injection
Time Frame: one hour after anesthesia
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one hour after anesthesia
|
heart rate modifications induced by anesthetic induction
Time Frame: one hour after anesthesia
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one hour after anesthesia
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patient's satisfaction
Time Frame: one day after anesthesia
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one day after anesthesia
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arterial pressure modifications induced by anesthetic induction
Time Frame: one hour after anesthesia
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one hour after anesthesia
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Disappearance of the eyelash reflex
Time Frame: One hour after anesthesia
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One hour after anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
April 17, 2012
First Submitted That Met QC Criteria
May 4, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
November 3, 2016
Last Update Submitted That Met QC Criteria
November 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/34
- 2011-002644-27 (Other Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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