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

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.

Study Overview

• Status: Terminated
• Conditions: Facial Bones Fracture
• Intervention / Treatment: Drug: Ramosetron

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Nasea®

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chanyeong Heo, Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 8, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: fractures; reduction; facial bones; Post operative nasea vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Fractures, Bone; Facies; Skull Fractures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Ramosetron
• Other Study ID Numbers: B-1107-131-007; L-2011-329-1 (Other Grant/Funding Number: Astellas Pharm. Co.)