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

This study is currently recruiting participants.
Verified March 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01637545
First received: July 8, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Facial Bones Fracture
 Drug: Ramosetron
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • incidence and severity of nausea and vomiting [ Time Frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient satisfaction with the effect [ Time Frame: at 24 h after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 99
Study Start Date: December 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Preop. ramosetron 0.3mg i.v.
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery
 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

Other Name: Nasea®
Active Comparator: Postop. ramosetron 0.3mg i.v.
G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
 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

Other Name: Nasea®
Active Comparator: No Ramosetron
G3 - No medication but regular antiemetics injection if the patient wants
 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

Other Name: Nasea®

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637545

Contacts
Contact: Chanyeong Heo, Ph.D. 82-31-787-7222 lionheo@snu.ac.kr
Contact: Jihoon Kim, Master 82-31-787-7229 89021@snubh.org

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Chanyeong Heo, Ph.D.     82-31-787-7222     lionheo@snu.ac.kr    
Contact: Jihoon Kim, Master     82-31-787-7229     89021@snubh.org    
Principal Investigator: Chanyeong Heo, Ph.D.            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chanyeong Heo, Ph.D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Chan-Yeong Heo, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01637545     History of Changes
Other Study ID Numbers: B-1107-131-007, L-2011-329-1
Study First Received: July 8, 2012
Last Updated: March 18, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
facial bones
Post operative nasea vomiting
fractures
reduction

Additional relevant MeSH terms:
Facies
Fractures, Bone
Skull Fractures
Disease Attributes
Pathologic Processes
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Antiemetics
Ramosetron
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013