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

NCT01637545 | Terminated Phase 4

• 2 other identifiers: B-1107-131-007L-2011-329-1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Bones Fracture

Keywords

facial bones; Post operative nasea vomiting; fractures; reduction

Outcome Measures

Primary Outcomes (1)

• incidence and severity of nausea and vomiting

  for 24 h after surgery at 0-6h, 6-12 h and 12-24 h

Secondary Outcomes (1)

• patient satisfaction with the effect

  at 24 h after surgery

Study Arms (3)

Preop. ramosetron 0.3mg i.v.

ACTIVE COMPARATOR

G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery

Drug: Ramosetron

Postop. ramosetron 0.3mg i.v.

ACTIVE COMPARATOR

G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room

Drug: Ramosetron

No Ramosetron

ACTIVE COMPARATOR

G3 - No medication but regular antiemetics injection if the patient wants

Drug: Ramosetron

Interventions

Ramosetron DRUG

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

Also known as: Nasea®

No Ramosetron; Postop. ramosetron 0.3mg i.v.; Preop. ramosetron 0.3mg i.v.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who sign informed consent form for the study
• patient who are considered as surgical candidates with facial bones fracture

You may not qualify if:

• Patient who have had nausea/vomiting episodes

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Chanyeong Heo, Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2012
• First Posted: July 11, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

KR (1)