Comparison of Different Propofol Formulations
Phase 4
Completed
- Conditions
- General Anesthesia
- Interventions
- Registration Number
- NCT01041872
- Lead Sponsor
- Hopital Foch
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
Inclusion Criteria
- patients scheduled for an intravenous induction of anesthesia with propofol
Read More
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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol Astrazeneca plus lidocaine 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-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 Fresenius plain 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 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. Propofol Astrazeneca 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-lipuro B. Braun plus lidocaine 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.
- Primary Outcome Measures
Name Time Method necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50) end of anesthetic induction
- Secondary Outcome Measures
Name Time Method calculated concentrations of propofol at the end of the anesthetic induction end of the anesthetic induction measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients) 3 months after the end of patient's recruitment pain at injection during the PACU (post-anaesthesia care unit) stay heart rate and arterial pressure modifications induced by anesthetic induction end of anesthetic induction patients satisfaction during the PACU stay necessary dose of propofol to obtain loss of consciousness end of anesthetic induction calculated concentrations of propofol at loss of consciousness end of anesthetic induction
Trial Locations
- Locations (3)
Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré
🇫🇷Garches, France
Clinique Saint Augustin
🇫🇷Bordeaux, France
Hôpital Foch
🇫🇷Suresnes, France