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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01592162
First received: April 17, 2012
Last updated: April 19, 2016
Last verified: April 2016
  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 ]

Enrollment: 409
Study Start Date: May 2013
Study Completion Date: November 2014
Primary Completion Date: November 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   (Adult, Senior)
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

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
  More Information

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: April 19, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 24, 2016