NCT01041872

Comparison of Different Propofol Formulations

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Anesthesia

Interventions

Type	Name	Description
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.
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.
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.
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.
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.
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-01-01
• Last updated: 2016-09-26

Locations

3 sites across 1 country: France