Comparison of Different Propofol Formulations

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 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.

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

Conditions
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General Anesthesia

Intervention / Treatment
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* Drug: Propofol Astrazeneca plain
* Drug: Propofol Astrazeneca plus lidocaine
* Drug: Propofol-lipuro B. Braun plain
* Drug: Propofol-lipuro B. Braun plus lidocaine
* Drug: Propofol Fresenius plain
* Drug: Propofol Fresenius plus lidocaine


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 lidocaine, 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol Astrazeneca<br>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. | Drug: Propofol Astrazeneca plain<br>* 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.<br>* Other names: Propofol Astrazeneca;|
| Experimental: Propofol Astrazeneca plus lidocaine<br>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. | Drug: Propofol Astrazeneca plus lidocaine<br>* 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.<br>* Other names: Propofol Astrazeneca, Lidocaine;|
| Experimental: Propofol-lipuro B. Braun plain<br>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. | Drug: Propofol-lipuro B. Braun plain<br>* 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.<br>* Other names: Propofol-lipuro B. Braun;|
| Experimental: Propofol-lipuro B. Braun plus lidocaine<br>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. | Drug: Propofol-lipuro B. Braun plus lidocaine<br>* 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.<br>* Other names: Propofol-lipuro B. Braun, lidocaine;|
| Experimental: Propofol Fresenius plain<br>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. | Drug: Propofol Fresenius plain<br>* 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.<br>* Other names: Propofol Fresenius;|
| Experimental: Propofol Fresenius plus lidocaine<br>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. | Drug: Propofol Fresenius plus lidocaine<br>* 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.<br>* Other names: Propofol Fresenius, lidocaine;|

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 of 50) |  | end of anesthetic induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |