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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01637545

Enrollment

Registered

2012-07-11

Start date

2011-12-31

Completion date

2015-02-28

Last updated

2015-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Bones Fracture

Keywords

facial bones, Post operative nasea vomiting, fractures, reduction

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

Interventions

DRUGRamosetron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
patient satisfaction with the effect	at 24 h after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026