Comparison of Different Propofol Formulations (Propofols)

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: General Anesthesia

Treatments: Drug: Propofol Fresenius plain; Drug: Propofol Fresenius plus lidocaine; Drug: Propofol-lipuro B. Braun plain; Drug: Propofol Astrazeneca plain; Drug: Propofol-lipuro B. Braun plus lidocaine; Drug: Propofol Astrazeneca plus lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01041872

2009/22

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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212 participants in 6 patient groups

Propofol Astrazeneca

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol Astrazeneca plain

Propofol Astrazeneca plus lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Propofol Astrazeneca plus lidocaine

Propofol-lipuro B. Braun plain

Experimental group

Description:

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.

Treatment:

Drug: Propofol-lipuro B. Braun plain

Propofol-lipuro B. Braun plus lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Propofol-lipuro B. Braun plus lidocaine

Propofol Fresenius plain

Experimental group

Description:

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.

Treatment:

Drug: Propofol Fresenius plain

Propofol Fresenius plus lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Propofol Fresenius plus lidocaine