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The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rémifentanil + Kétamine | Other | to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. |
|
| Rémifentanil + Placebo | Other | to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rémifentamil + KETAMINE | Drug | All consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of opiate used between study enrollment and mechanical ventilation withdrawal. | after 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Confusion Duration assessed by CAM-ICU | after 24 hours | |
| mechanical ventilation duration | after 24 hours | |
| ICU length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel CONSTANTIN | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D003221 | Confusion |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| ketamine | Drug | to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine. |
|
| after 24 hours |
| Mortality at D28 | at day 28 |
| hyperalgesia during sedation | after 24 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |