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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002644-27 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol 1% (Astra-Zeneca) - remi 0 | Active Comparator | propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml |
|
| propofol 1% (Astra-Zeneca) - remi 2 | Active Comparator | propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml |
|
| propofol 1% (Astra-Zeneca) - remi 4 | Active Comparator | propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml |
|
| propofol 1% (Fresenius) - remi 0 | Active Comparator | propofol 1% (Fresenius) plus remifentanil 0 ng/ml |
|
| propofol 1% (Fresenius) - remi 2 | Active Comparator | propofol 1% (Fresenius) plus remifentanil 2 ng/ml |
|
| propofol 1% (Fresenius) - remi 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol (Astra-Zeneca), NaCl 0.9% | Drug | propofol administered by a closed-loop system and saline |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Besançon | 25034 | France | |||
| Hopital Foch |
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propofol 1% (Fresenius) plus remifentanil 4 ng/ml |
|
| propofol 1% (B-Braun) - remi 0 | Active Comparator | propofol 1% (B-Braun) plus remifentanil 0 ng/ml |
|
| propofol 1% (B-Braun) - remi 2 | Active Comparator | propofol 1% (B-Braun) plus remifentanil 2 ng/ml |
|
| propofol 1% (B-Braun) - remi 4 | Active Comparator | propofol 1% (B-Braun) plus remifentanil 4 ng/ml |
|
| propofol 1% (Astra-Zeneca) and remifentanil | Drug | propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion) |
|
| propofol 1% (Astra-Zeneca) and remifentanil | Drug | propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion) |
|
| Propofol (Astra-Zeneca), NaCl 0.9% | Drug | propofol administered by a closed-loop system and saline |
|
| Propofol (Astra-Zeneca) and remifentanil | Drug | propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion) |
|
| Propofol (Astra-Zeneca) and remifentanil | Drug | propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion) |
|
| Propofol (B-Braun) and NaCl 0.9% | Drug | propofol administered by a closed-loop system and saline |
|
| Propofol (B-Braun) and remifentanil | Drug | propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion) |
|
| Propofol (B-Braun) and remifentanil | Drug | propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion) |
|
| 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 |
| Suresnes |
| Île-de-France Region |
| 92151 |
| France |
| ID | Term |
|---|---|
| D015742 | Propofol |
| D012965 | Sodium Chloride |
| D000077208 | Remifentanil |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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