Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine
Overview
- Phase
- Phase 4
- Intervention
- Propofol Astrazeneca plain
- Conditions
- General Anesthesia
- Sponsor
- Hopital Foch
- Enrollment
- 212
- Locations
- 3
- Primary Endpoint
- necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
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.
Intervention: Propofol Astrazeneca plain
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.
Intervention: Propofol Astrazeneca plus 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.
Intervention: Propofol-lipuro B. Braun plain
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.
Intervention: Propofol-lipuro B. Braun plus 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.
Intervention: Propofol Fresenius plain
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.
Intervention: Propofol Fresenius plus lidocaine
Outcomes
Primary Outcomes
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
Time Frame: end of anesthetic induction
Secondary Outcomes
- 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)