Comparison of Different Propofol Formulations

General Anesthesia Clinical Trial

— Propofols  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041872
• Other study ID #: 2009/22
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2009
• Last updated: September 23, 2016
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Clinique Saint Augustin	Bordeaux
France	Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré	Garches
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)		end of anesthetic induction	No
Secondary	calculated concentrations of propofol at the end of the anesthetic induction		end of the anesthetic induction	No
Secondary	measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)		3 months after the end of patient's recruitment	No
Secondary	pain at injection		during the PACU (post-anaesthesia care unit) stay	No
Secondary	heart rate and arterial pressure modifications induced by anesthetic induction		end of anesthetic induction	No
Secondary	patients satisfaction		during the PACU stay	No
Secondary	necessary dose of propofol to obtain loss of consciousness		end of anesthetic induction	No
Secondary	calculated concentrations of propofol at loss of consciousness		end of anesthetic induction	No