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

Facial Bones Fracture Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Facial Bones Fracture
• Facies
• Fractures, Bone
• Skull Fractures

• NCT number: NCT01637545
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: December 2011
• Completion date: February 2015