Comparison of Different Propofol Formulations

Condition(s) targeted: General Anesthesia

Intervention: Propofol Astrazeneca plain (Drug); Propofol Astrazeneca plus lidocaine (Drug); Propofol-lipuro B. Braun plain (Drug); Propofol-lipuro B. Braun plus lidocaine (Drug); Propofol Fresenius plain (Drug); Propofol Fresenius plus lidocaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hopital Foch

Official(s) and/or principal investigator(s):
Morgan LeGuen, MD, Principal Investigator, Affiliation: Hôpital Foch

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)

Secondary outcome:

calculated concentrations of propofol at the end of the anesthetic induction

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

pain at injection

heart rate and arterial pressure modifications induced by anesthetic induction

patients satisfaction

necessary dose of propofol to obtain loss of consciousness

calculated concentrations of propofol at loss of consciousness

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Clinique Saint Augustin, Bordeaux 33000, France

Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré, Garches 92380, France

Hôpital Foch, Suresnes 92151, France

Related publications:

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

Starting date: December 2009
Last updated: July 18, 2011