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

Primary Purpose

Facial Bones Fracture

Status

Terminated

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ramosetron

About this trial

This is an interventional prevention trial for Facial Bones Fracture focused on measuring facial bones, Post operative nasea vomiting, fractures, reduction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Preop. ramosetron 0.3mg i.v.

Postop. ramosetron 0.3mg i.v.

No Ramosetron

Arm Description

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 wants

Outcomes

Primary Outcome Measures

incidence and severity of nausea and vomiting

Secondary Outcome Measures

patient satisfaction with the effect

Full Information

NCT ID

NCT01637545

First Posted

July 8, 2012

Last Updated

May 7, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01637545

Brief Title

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

Official Title

Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

Principal Investigator is away on business

Study Start Date

December 2011 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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

Participants 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups 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 The primary endpoint the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h The secondary endpoints the severity of nausea, need for rescue medication patient satisfaction with efficacy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Bones Fracture

Keywords

facial bones, Post operative nasea vomiting, fractures, reduction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preop. ramosetron 0.3mg i.v.

Arm Type

Active Comparator

Arm Description

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

Arm Title

Postop. ramosetron 0.3mg i.v.

Arm Type

Active Comparator

Arm Description

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

Arm Title

No Ramosetron

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ramosetron

Other Intervention Name(s)

Nasea®

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

patient satisfaction with the effect

Time Frame

at 24 h after surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chanyeong Heo, Ph.D.

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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