Comparison of Different Propofol Formulations (Propofols)

September 23, 2016 updated by: Hopital Foch

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Clinique Saint Augustin
      • Garches, France, 92380
        • Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré
      • Suresnes, France, 92151
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Propofol Astrazeneca
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.
Drug: Propofol Astrazeneca plain
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
EXPERIMENTAL: Propofol Astrazeneca plus lidocaine
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.
Drug: Propofol Astrazeneca plus lidocaine
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
EXPERIMENTAL: Propofol-lipuro B. Braun plain
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.
Drug: Propofol-lipuro B. Braun plain
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
EXPERIMENTAL: Propofol-lipuro B. Braun plus lidocaine
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.
Drug: Propofol-lipuro B. Braun plus lidocaine
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
EXPERIMENTAL: Propofol Fresenius plain
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.
Drug: Propofol Fresenius plain
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
EXPERIMENTAL: Propofol Fresenius plus lidocaine
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.
Drug: Propofol Fresenius plus lidocaine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
Time Frame: end of anesthetic induction
end of anesthetic induction

Secondary Outcome Measures

Outcome Measure
Time Frame
calculated concentrations of propofol at the end of the anesthetic induction
Time Frame: end of the anesthetic induction
end of the anesthetic induction
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 months after the end of patient's recruitment
pain at injection
Time Frame: during the PACU (post-anaesthesia care unit) stay
during the PACU (post-anaesthesia care unit) stay
heart rate and arterial pressure modifications induced by anesthetic induction
Time Frame: end of anesthetic induction
end of anesthetic induction
patients satisfaction
Time Frame: during the PACU stay
during the PACU stay
necessary dose of propofol to obtain loss of consciousness
Time Frame: end of anesthetic induction
end of anesthetic induction
calculated concentrations of propofol at loss of consciousness
Time Frame: end of anesthetic induction
end of anesthetic induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Morgan LeGuen, MD, Hôpital FOCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

December 31, 2009

First Submitted That Met QC Criteria

December 31, 2009

First Posted (ESTIMATE)

January 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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