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A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Amisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia |
|
| Placebo | Placebo Comparator | Placebo was given by slow iv administration during1 to 2 min at induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amisulpride | Drug | 5mg/2ml |
| |
| Amisulpride Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was the composite measure complete response | defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure | 24 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of no Nausea | Count of patients experiencing an episode of no nausea scored < 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery | 24 hours after end of surgery |
| Incidence of moderate and severe Nausea |
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Inclusion Criteria:
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yi feng | Contact | 010-88325988 | yifeng65@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| yi feng | Peking University People's Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Drug |
2ml |
|
Count of participants with nausea score > 4 on 0-10 verbal response scale |
| 24 hours after end of surgery |
| Incidence of Emesis (Vomiting/Retching) | An assessment of a participant experiencing an episode of emesis (vomiting/ retching) during the 24hours after the completion of the surgery | 24 hours after end of surgery |
| Use of Rescue Medication | 24 hours after end of surgery |
| Time to First Violation of Criteria for PONV | Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery | 24 hours after end of surgery |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |