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

This study has been terminated.
(Principal Investigator is away on business)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637545
First Posted: July 11, 2012
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by Chan-Yeong Heo, 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 ]

Secondary Outcome Measures:
  • patient satisfaction with the effect [ Time Frame: at 24 h after surgery ]

Enrollment: 49
Study Start Date: December 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637545


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chanyeong Heo, Ph.D. Seoul National University Bundang Hospital
  More Information

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 ( Other Grant/Funding Number: Astellas Pharm. Co. )
First Submitted: July 8, 2012
First Posted: July 11, 2012
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Chan-Yeong Heo, Seoul National University Hospital:
facial bones
Post operative nasea vomiting
fractures
reduction

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