NCT01637545

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Facial Bones Fracture

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-07-11
• Last updated: 2015-05-08

Locations

1 site across 1 country: South Korea