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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003001-97 | EudraCT Number |
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The objective is to evaluate the sparing effect of ketamine on the dose of propofol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Ketamine (bolus dose of Ketamine (0.15 mg.kg-1) followed by an infusion of Ketamine (0.15 mg.kg-1 h-1) until the end of anesthesia) |
|
| Placebo | Experimental | patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo (NaCl 9/00 (same volume as in the Ketamine group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| administered dose of propofol during maintenance of anesthesia | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| bispectral index measurement | bispectral index modification due to ketamine infusion before induction of anesthesia | 1 day |
| administered dose of propofol during induction of anesthesia | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hôpital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | Hauts de Seine | 92151 | France | ||
| Clinique Fontaine les Dijons |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| administered doses of remifentanil during induction and maintenance of anesthesia | day 1 |
| delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia | day 1 |
| hemodynamic abnormalities requiring treatment | day 1 |
| % of time with a bispectral index between 40 and 60 | day 1 |
| postoperative morphine requirement | day 1 |
| incidence of postoperative nausea and vomiting | day 1 |
| White and Song score | day 1 |
| % of patients with an explicit memorisation of the intraoperative period | second postoperative day |
| Fontaine-lès-Dijon |
| 21121 |
| France |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |