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Completed

NCT Number: NCT01592162

Comparison of Different Propofol Formulations With or Without Remifentanil

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Foch, Suresnes, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol (Astra-Zeneca), NaCl 0.9%

Drug

propofol administered by a closed-loop system and saline

propofol 1% (Astra-Zeneca) and remifentanil

Drug

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

Propofol (Astra-Zeneca) and remifentanil

Drug

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

Propofol (B-Braun) and NaCl 0.9%

Drug

propofol administered by a closed-loop system and saline

Propofol (B-Braun) and remifentanil

Drug

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

Primary outcomes

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

    Time frame: one hour after anesthesia

Secondary outcomes

  1. calculated concentrations of propofol at the end of the anesthetic induction

    Time frame: one hour after anesthesia

  2. pain at injection

    Time frame: one hour after anesthesia

  3. heart rate modifications induced by anesthetic induction

    Time frame: one hour after anesthesia

  4. patient's satisfaction

    Time frame: one day after anesthesia

  5. arterial pressure modifications induced by anesthetic induction

    Time frame: one hour after anesthesia

  6. Disappearance of the eyelash reflex

    Time frame: One hour after anesthesia

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: PropofolRemi

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 7, 2012
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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