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

Phase 4

Terminated

• Conditions: Facial Bones Fracture
• Interventions: Drug: Ramosetron

• Registration Number: NCT01637545
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

1. Participants

* 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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postop. ramosetron 0.3mg i.v.	Ramosetron	G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
Preop. ramosetron 0.3mg i.v.	Ramosetron	G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery
No Ramosetron	Ramosetron	G3 - No medication but regular antiemetics injection if the patient wants

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
patient satisfaction with the effect	at 24 h after surgery

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of