Comparison of Different Propofol Formulations With or Without Remifentanil

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: propofol 1% (Astra-Zeneca) and remifentanil; Drug: Propofol (B-Braun) and remifentanil; Drug: Propofol (B-Braun) and NaCl 0.9%; Drug: Propofol (Astra-Zeneca), NaCl 0.9%; Drug: Propofol (Astra-Zeneca) and remifentanil

• Registration Number: NCT01592162
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Study Start: 2013-05
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 409

Inclusion Criteria

• Patients scheduled for an intravenous induction of anesthesia with propofol

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol 1% (Astra-Zeneca) - remi 4	propofol 1% (Astra-Zeneca) and remifentanil	propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml
propofol 1% (B-Braun) - remi 4	Propofol (B-Braun) and remifentanil	propofol 1% (B-Braun) plus remifentanil 4 ng/ml
propofol 1% (B-Braun) - remi 0	Propofol (B-Braun) and NaCl 0.9%	propofol 1% (B-Braun) plus remifentanil 0 ng/ml
propofol 1% (Fresenius) - remi 0	Propofol (Astra-Zeneca), NaCl 0.9%	propofol 1% (Fresenius) plus remifentanil 0 ng/ml
propofol 1% (Astra-Zeneca) - remi 0	Propofol (Astra-Zeneca), NaCl 0.9%	propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml
propofol 1% (Fresenius) - remi 2	Propofol (Astra-Zeneca) and remifentanil	propofol 1% (Fresenius) plus remifentanil 2 ng/ml
propofol 1% (Astra-Zeneca) - remi 2	propofol 1% (Astra-Zeneca) and remifentanil	propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml
propofol 1% (Fresenius) - remi 4	Propofol (Astra-Zeneca) and remifentanil	propofol 1% (Fresenius) plus remifentanil 4 ng/ml
propofol 1% (B-Braun) - remi 2	Propofol (B-Braun) and remifentanil	propofol 1% (B-Braun) plus remifentanil 2 ng/ml

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Hopital Foch; 🇫🇷 Suresnes, Ile de France, France

CHU Besançon; 🇫🇷 Besançon, France