Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
Overview
- Phase
- Phase 4
- Intervention
- Propofol (Astra-Zeneca), NaCl 0.9%
- Conditions
- Anesthesia
- Sponsor
- Hopital Foch
- Enrollment
- 409
- Locations
- 2
- Primary Endpoint
- necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
- 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 remifentanil) on anesthetic induction. Propofol plain or with remifentanil 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 remifentanil,
- •History of central neurological disorder or brain injury,
- •Patients receiving psychotropic drugs,
- •Patient with a pacemaker
Arms & Interventions
propofol 1% (Astra-Zeneca) - remi 0
propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml
Intervention: Propofol (Astra-Zeneca), NaCl 0.9%
propofol 1% (Astra-Zeneca) - remi 2
propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml
Intervention: propofol 1% (Astra-Zeneca) and remifentanil
propofol 1% (Astra-Zeneca) - remi 4
propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml
Intervention: propofol 1% (Astra-Zeneca) and remifentanil
propofol 1% (Fresenius) - remi 0
propofol 1% (Fresenius) plus remifentanil 0 ng/ml
Intervention: Propofol (Astra-Zeneca), NaCl 0.9%
propofol 1% (Fresenius) - remi 2
propofol 1% (Fresenius) plus remifentanil 2 ng/ml
Intervention: Propofol (Astra-Zeneca) and remifentanil
propofol 1% (Fresenius) - remi 4
propofol 1% (Fresenius) plus remifentanil 4 ng/ml
Intervention: Propofol (Astra-Zeneca) and remifentanil
propofol 1% (B-Braun) - remi 0
propofol 1% (B-Braun) plus remifentanil 0 ng/ml
Intervention: Propofol (B-Braun) and NaCl 0.9%
propofol 1% (B-Braun) - remi 2
propofol 1% (B-Braun) plus remifentanil 2 ng/ml
Intervention: Propofol (B-Braun) and remifentanil
propofol 1% (B-Braun) - remi 4
propofol 1% (B-Braun) plus remifentanil 4 ng/ml
Intervention: Propofol (B-Braun) and remifentanil
Outcomes
Primary Outcomes
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
Time Frame: one hour after anesthesia
Secondary Outcomes
- pain at injection(one hour after anesthesia)
- patient's satisfaction(one day after anesthesia)
- calculated concentrations of propofol at the end of the anesthetic induction(one hour after anesthesia)
- Disappearance of the eyelash reflex(One hour after anesthesia)
- heart rate modifications induced by anesthetic induction(one hour after anesthesia)
- arterial pressure modifications induced by anesthetic induction(one hour after anesthesia)