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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000905-22 | EudraCT Number |
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The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 : Droperidol 1,25 mg | Active Comparator |
| |
| Arm 2 : Droperidol 0,625 mg | Active Comparator |
| |
| Arm 3 : Odansetron 4 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of akathisia | The main objective of this study was to evaluate the incidence of akathisia with the waning of prophylactic treatment of PONV with droperidol used two different doses versus control group (ondansetron), ambulatory surgery | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Hôpitaux Universitaires de Strasbourg | Strasbourg | Alsace | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29746373 | Result | Charton A, Greib N, Ruimy A, Faitot V, Noudem Y, Joshi GP, Meyer N, Diemunsch P. Incidence of akathisia after postoperative nausea and vomiting prophylaxis with droperidol and ondansetron in outpatient surgery: A multicentre controlled randomised trial. Eur J Anaesthesiol. 2018 Dec;35(12):966-971. doi: 10.1097/EJA.0000000000000821. |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D006298 | Health Services Administration |
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| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |