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

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: Anesthesia
• 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

Study Locations

• France
  • Besançon, France, 25034
    • CHU Besançon
  • Ile de France
    • Suresnes, Ile de France, France, 92151
      • Hopital Foch

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

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	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); 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% (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 (2 ng/ml, target controled infusion); 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); 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% (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 (2 ng/ml, target controled infusion); 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); Drug: Propofol (B-Braun) and remifentanil; 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	Drug: Propofol (B-Braun) and remifentanil; propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion); Drug: Propofol (B-Braun) and remifentanil; 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)	one hour after anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
calculated concentrations of propofol at the end of the anesthetic induction	one hour after anesthesia
pain at injection	one hour after anesthesia
heart rate modifications induced by anesthetic induction	one hour after anesthesia
patient's satisfaction	one day after anesthesia
arterial pressure modifications induced by anesthetic induction	one hour after anesthesia
Disappearance of the eyelash reflex	One hour after anesthesia

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

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: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: 2011/34; 2011-002644-27 (Other Identifier: ANSM)