NCT01592162

Comparison of Different Propofol Formulations With or Without Remifentanil

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Propofol (Astra-Zeneca), NaCl 0.9%	propofol administered by a closed-loop system and saline
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)
DRUG	Propofol (Astra-Zeneca), NaCl 0.9%	propofol administered by a closed-loop system and saline
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)
DRUG	Propofol (B-Braun) and NaCl 0.9%	propofol administered by a closed-loop system and saline
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)

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-05-07
• Last updated: 2016-11-03

Locations

2 sites across 1 country: France