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NCT01592162 Clinical Trial

Comparison of Different Propofol Formulations With or Without Remifentanil

Anesthesia Clinical Trial

— PropofolRemi  

Official title:
Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01592162
Other study ID # 2011/34
Secondary ID 2011-002644-27
Status Completed
Phase Phase 4
First received April 17, 2012
Last updated November 2, 2016
Start date May 2013
Est. completion date November 2014

Study information
Verified date November 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 409
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
• propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
• propofol 1% (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
• Propofol (Astra-Zeneca), NaCl 0.9%
propofol administered by a closed-loop system and saline
• Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
• Propofol (Astra-Zeneca) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
• Propofol (B-Braun) and NaCl 0.9%
propofol administered by a closed-loop system and saline
• Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
• Propofol (B-Braun) and remifentanil
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)

Locations
Country Name City State
France CHU Besançon Besançon
France Hopital Foch Suresnes Ile de France

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds) one hour after anesthesia No
Secondary calculated concentrations of propofol at the end of the anesthetic induction one hour after anesthesia No
Secondary pain at injection one hour after anesthesia No
Secondary heart rate modifications induced by anesthetic induction one hour after anesthesia No
Secondary patient's satisfaction one day after anesthesia No
Secondary arterial pressure modifications induced by anesthetic induction one hour after anesthesia No
Secondary Disappearance of the eyelash reflex One hour after anesthesia No
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