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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol Astrazeneca | Active Comparator | 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. |
|
| Propofol Astrazeneca plus lidocaine | Experimental | 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. |
|
| Propofol-lipuro B. Braun plain | Experimental | 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. |
|
| Propofol-lipuro B. Braun plus lidocaine | Experimental | 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. |
|
| Propofol Fresenius plain | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol Astrazeneca plain | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morgan LeGuen, MD | Hôpital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Augustin | Bordeaux | 33000 | France | |||
| Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16571963 | Background | Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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. |
|
| Propofol Fresenius plus lidocaine | Experimental | 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. |
|
|
| Propofol Astrazeneca plus lidocaine | Drug | 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. |
|
|
| Propofol-lipuro B. Braun plain | Drug | 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. |
|
|
| Propofol-lipuro B. Braun plus lidocaine | Drug | 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. |
|
|
| Propofol Fresenius plain | Drug | 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. |
|
|
| Propofol Fresenius plus lidocaine | Drug | 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. |
|
|
| 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 |
| Garches |
| 92380 |
| France |
| Hôpital Foch | Suresnes | 92151 | France |
| Aniline Compounds |
| D000588 | Amines |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |