Comparison of Different Propofol Formulations With or Without Remifentanil

Study Overview
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Brief Summary
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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.

Official Title
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Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Propofol (Astra-Zeneca), NaCl 0.9%
* Drug: propofol 1% (Astra-Zeneca) and remifentanil
* Drug: propofol 1% (Astra-Zeneca) and remifentanil
* Drug: Propofol (Astra-Zeneca), NaCl 0.9%
* Drug: Propofol (Astra-Zeneca) and remifentanil
* Drug: Propofol (Astra-Zeneca) and remifentanil
* Drug: Propofol (B-Braun) and NaCl 0.9%
* Drug: Propofol (B-Braun) and remifentanil
* Drug: Propofol (B-Braun) and remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol 1% (Astra-Zeneca) - remi 0<br>propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml | Drug: Propofol (Astra-Zeneca), NaCl 0.9%<br>* propofol administered by a closed-loop system and saline<br>|
| Active Comparator: propofol 1% (Astra-Zeneca) - remi 2<br>propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml | Drug: propofol 1% (Astra-Zeneca) and remifentanil<br>* propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)<br>|
| Active Comparator: propofol 1% (Astra-Zeneca) - remi 4<br>propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml | Drug: propofol 1% (Astra-Zeneca) and remifentanil<br>* propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)<br>|
| Active Comparator: propofol 1% (Fresenius) - remi 0<br>propofol 1% (Fresenius) plus remifentanil 0 ng/ml | Drug: Propofol (Astra-Zeneca), NaCl 0.9%<br>* propofol administered by a closed-loop system and saline<br>|
| Active Comparator: propofol 1% (Fresenius) - remi 2<br>propofol 1% (Fresenius) plus remifentanil 2 ng/ml | Drug: Propofol (Astra-Zeneca) and remifentanil<br>* propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)<br>|
| Active Comparator: propofol 1% (Fresenius) - remi 4<br>propofol 1% (Fresenius) plus remifentanil 4 ng/ml | Drug: Propofol (Astra-Zeneca) and remifentanil<br>* propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)<br>|
| Active Comparator: propofol 1% (B-Braun) - remi 0<br>propofol 1% (B-Braun) plus remifentanil 0 ng/ml | Drug: Propofol (B-Braun) and NaCl 0.9%<br>* propofol administered by a closed-loop system and saline<br>|
| Active Comparator: propofol 1% (B-Braun) - remi 2<br>propofol 1% (B-Braun) plus remifentanil 2 ng/ml | Drug: Propofol (B-Braun) and remifentanil<br>* propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)<br>|
| Active Comparator: propofol 1% (B-Braun) - remi 4<br>propofol 1% (B-Braun) plus remifentanil 4 ng/ml | Drug: Propofol (B-Braun) and remifentanil<br>* propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds) |  | one hour after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calculated concentrations of propofol at the end of the anesthetic induction |  | one hour after anesthesia | 
| pain at injection |  | one hour after anesthesia | 
| heart rate modifications induced by anesthetic induction |  | one hour after anesthesia | 
| patient's satisfaction |  | one day after anesthesia | 
| arterial pressure modifications induced by anesthetic induction |  | one hour after anesthesia | 
| Disappearance of the eyelash reflex |  | One hour after anesthesia |