Comparison of Different Propofol Formulations - Full Text View

Purpose

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.

Condition	Intervention	Phase
General Anesthesia	Drug: 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	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Lidocaine Propofol

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:

necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50) [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

calculated concentrations of propofol at the end of the anesthetic induction [ Time Frame: end of the anesthetic induction ] [ Designated as safety issue: No ]
measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients) [ Time Frame: 3 months after the end of patient's recrutement ] [ Designated as safety issue: No ]
pain at injection [ Time Frame: during the PACU stay ] [ Designated as safety issue: No ]
heart rate and arterial pressure modifications induced by anesthetic induction [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]
patients satisfaction [ Time Frame: during the PACU stay ] [ Designated as safety issue: No ]
necessary dose of propofol to obtain loss of consciousness [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]
calculated concentrations of propofol at loss of consciousness [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	December 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Propofol Fresenius, lidocaine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041872

Locations

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

Sponsors and Collaborators

Hopital Foch

Investigators

Principal Investigator:

Morgan LeGuen, MD

Hôpital Foch

More Information

Publications:

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe 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.

Responsible Party:	Dr Marc Fischler, Hôpital Foch
ClinicalTrials.gov Identifier:	NCT01041872 History of Changes
Other Study ID Numbers:	2009/22
Study First Received:	December 31, 2009
Last Updated:	July 18, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013

Comparison of Different Propofol Formulations (Propofols)