Comparison of Different Propofol Formulations With or Without Remifentanil

Hopital Foch409 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

409

Conditions

Anesthesia

Interventions

Propofol (Astra-Zeneca), NaCl 0.9%DRUG

propofol administered by a closed-loop system and saline

propofol 1% (Astra-Zeneca) and remifentanilDRUG

propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)

propofol 1% (Astra-Zeneca) and remifentanilDRUG

propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHU Besançon

Besançon, France

Hopital Foch

Suresnes, Île-de-France Region, France

Outcomes

Primary Outcomes

necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)