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| ID | Type | Description | Link |
|---|---|---|---|
| L-2011-329-1 | Other Grant/Funding Number | Astellas Pharm. Co. |
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Principal Investigator is away on business
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Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.
Participants
Randomization
The primary endpoint
The secondary endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preop. ramosetron 0.3mg i.v. | Active Comparator | G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery |
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| Postop. ramosetron 0.3mg i.v. | Active Comparator | G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room |
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| No Ramosetron | Active Comparator | G3 - No medication but regular antiemetics injection if the patient wants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramosetron | Drug | G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room G3 - No medication but regular antiemetics injection if the patient want |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of nausea and vomiting | for 24 h after surgery at 0-6h, 6-12 h and 12-24 h |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction with the effect | at 24 h after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chanyeong Heo, Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
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