Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations
NCT ID: NCT01637545
Last Updated: 2015-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
49 participants
INTERVENTIONAL
2011-12-31
2015-02-28
Brief Summary
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Detailed Description
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* 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
2. Randomization
* G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
* G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
* G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
3. The primary endpoint
* the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
4. The secondary endpoints
* the severity of nausea, need for rescue medication
* patient satisfaction with efficacy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Preop. ramosetron 0.3mg i.v.
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery
Ramosetron
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
Postop. ramosetron 0.3mg i.v.
G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
Ramosetron
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
No Ramosetron
G3 - No medication but regular antiemetics injection if the patient wants
Ramosetron
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
Interventions
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Ramosetron
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient who are considered as surgical candidates with facial bones fracture
Exclusion Criteria
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Chan-Yeong Heo
Assistant Professor
Principal Investigators
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Chanyeong Heo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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L-2011-329-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
B-1107-131-007
Identifier Type: -
Identifier Source: org_study_id
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