Skip to main content
OpenTrials
Completed

NCT Number: NCT01041872

Comparison of Different Propofol Formulations

The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinique Saint Augustin, Bordeaux, 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 lidocaine,
  • History of central neurological disorder or brain injury,
  • Patients receiving psychotropic drugs,
  • Patient with a pacemaker.

Treatment and study plan

Propofol Astrazeneca plain

Drug

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Other names: Propofol Astrazeneca

Propofol Astrazeneca plus lidocaine

Drug

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Other names: Propofol Astrazeneca, Lidocaine

Propofol-lipuro B. Braun plain

Drug

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Other names: Propofol-lipuro B. Braun

Propofol-lipuro B. Braun plus lidocaine

Drug

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Other names: Propofol-lipuro B. Braun, lidocaine

Propofol Fresenius plain

Drug

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Other names: Propofol Fresenius

Propofol Fresenius plus lidocaine

Drug

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Other names: Propofol Fresenius, lidocaine

Primary outcomes

  1. necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)

    Time frame: end of anesthetic induction

Secondary outcomes

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

    Time frame: end of the anesthetic induction

  2. measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)

    Time frame: 3 months after the end of patient's recruitment

  3. pain at injection

    Time frame: during the PACU (post-anaesthesia care unit) stay

  4. heart rate and arterial pressure modifications induced by anesthetic induction

    Time frame: end of anesthetic induction

  5. patients satisfaction

    Time frame: during the PACU stay

  6. necessary dose of propofol to obtain loss of consciousness

    Time frame: end of anesthetic induction

  7. calculated concentrations of propofol at loss of consciousness

    Time frame: end of anesthetic induction

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 Lidocaine

Acronym: Propofols

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 1, 2010
Registry last updated
Sep 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.