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Comparison of Different Propofol Formulations With or Without Remifentanil (PropofolRemi)

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ClinicalTrials.gov Identifier: NCT01592162
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Propofol (Astra-Zeneca), NaCl 0.9% Drug: propofol 1% (Astra-Zeneca) and remifentanil Drug: Propofol (Astra-Zeneca) and remifentanil Drug: Propofol (B-Braun) and NaCl 0.9% Drug: Propofol (B-Braun) and remifentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
Study Start Date : May 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: propofol 1% (Astra-Zeneca) - remi 0
propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml
Drug: Propofol (Astra-Zeneca), NaCl 0.9%
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
Drug: propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Active Comparator: propofol 1% (Astra-Zeneca) - remi 4
propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml
Drug: propofol 1% (Astra-Zeneca) and remifentanil
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
Drug: Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
Active Comparator: propofol 1% (Fresenius) - remi 2
propofol 1% (Fresenius) plus remifentanil 2 ng/ml
Drug: Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Active Comparator: propofol 1% (Fresenius) - remi 4
propofol 1% (Fresenius) plus remifentanil 4 ng/ml
Drug: Propofol (Astra-Zeneca) and remifentanil
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
Drug: Propofol (B-Braun) and NaCl 0.9%
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
Drug: Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Active Comparator: propofol 1% (B-Braun) - remi 4
propofol 1% (B-Braun) plus remifentanil 4 ng/ml
Drug: Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. calculated concentrations of propofol at the end of the anesthetic induction [ Time Frame: one hour after anesthesia ]
  2. pain at injection [ Time Frame: one hour after anesthesia ]
  3. heart rate modifications induced by anesthetic induction [ Time Frame: one hour after anesthesia ]
  4. patient's satisfaction [ Time Frame: one day after anesthesia ]
  5. arterial pressure modifications induced by anesthetic induction [ Time Frame: one hour after anesthesia ]
  6. Disappearance of the eyelash reflex [ Time Frame: One hour after anesthesia ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592162


Locations
France
Hopital Foch
Suresnes, Ile de France, France, 92151
CHU Besançon
Besançon, France, 25034
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01592162     History of Changes
Other Study ID Numbers: 2011/34
2011-002644-27 ( Other Identifier: ANSM )
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents