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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01592162
First received: April 17, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • calculated concentrations of propofol at the end of the anesthetic induction [ Time Frame: one hour after anesthesia ] [ Designated as safety issue: No ]
  • pain at injection [ Time Frame: one hour after anesthesia ] [ Designated as safety issue: No ]
  • heart rate modifications induced by anesthetic induction [ Time Frame: one hour after anesthesia ] [ Designated as safety issue: No ]
  • patient's satisfaction [ Time Frame: one day after anesthesia ] [ Designated as safety issue: No ]
  • arterial pressure modifications induced by anesthetic induction [ Time Frame: one hour after anesthesia ] [ Designated as safety issue: No ]
  • Disappearance of the eyelash reflex [ Time Frame: One hour after anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592162

Contacts
Contact: Morgan Le Guen, MD 46252442 ext 00331 m.leguen@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, Ile de France, France, 92151
Contact: Morgan Le Guen, MD    46252442 ext 00331    m.leguen@hopital-foch.org   
Principal Investigator: Morgan LeGuen, MD         
Sub-Investigator: Kerstin Sievert, MD         
CHU Besançon Recruiting
Besançon, France, 25034
Contact: Nathalie Boichut, MD    81 21 83 78 ext 00333    nboichut@chu-besancon.fr   
Principal Investigator: Nathalie Boichut, MD         
Clinique Saint Augustin Recruiting
Bordeaux, France, 33000
Contact: Antoine Genty, MD    56 00 30 57 ext 00335    antoinegenty@aol.com   
Principal Investigator: Antoine Genty, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01592162     History of Changes
Other Study ID Numbers: 2011/34
Study First Received: April 17, 2012
Last Updated: December 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 22, 2014