General Anesthesia
Conditions
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.
Interventions
DRUGPropofol 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.
DRUGPropofol 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.
DRUGPropofol-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.
DRUGPropofol-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.
DRUGPropofol 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.
DRUGPropofol 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.
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50) | end of anesthetic induction |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| calculated concentrations of propofol at the end of the anesthetic induction | end of the anesthetic induction |
| 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 |
| patients satisfaction | during the PACU stay |
Countries
France
Outcome results
None listed