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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01637545
• Other study ID #: B-1107-131-007
• Secondary ID: L-2011-329-1
• Status: Terminated
• Phase: Phase 4
• First received: July 8, 2012
• Last updated: May 7, 2015
• Start date: December 2011
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of nausea and vomiting		for 24 h after surgery at 0-6h, 6-12 h and 12-24 h	No
Secondary	patient satisfaction with the effect		at 24 h after surgery	Yes