Comparison of Different Propofol Formulations With or Without Remifentanil

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

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)

Sponsors & Collaborators

• Hopital Foch

  lead OTHER

Principal Investigators

• Marc Fischler, MD · Hopital Foch

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• France

Study Locations