Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups 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 The primary endpoint the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h The secondary endpoints the severity of nausea, need for rescue medication patient satisfaction with efficacy

Official Title
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Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations

Conditions
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Facial Bones Fracture

Intervention / Treatment
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* Drug: Ramosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who sign informed consent form for the study patient who are considered as surgical candidates with facial bones fracture Exclusion Criteria: Patient who have had nausea/vomiting episodes
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preop. ramosetron 0.3mg i.v.<br>G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery | Drug: Ramosetron<br>* 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<br>* Other names: Nasea®;|
| Active Comparator: Postop. ramosetron 0.3mg i.v.<br>G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room | Drug: Ramosetron<br>* 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<br>* Other names: Nasea®;|
| Active Comparator: No Ramosetron<br>G3 - No medication but regular antiemetics injection if the patient wants | Drug: Ramosetron<br>* 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<br>* Other names: Nasea®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction with the effect |  | at 24 h after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial bones, Post operative nasea vomiting, fractures, reduction