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Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Laparoscopy for benign gynecologic disease

Exclusion Criteria:

  • Vomiting within 24 hours before surgery
  • Not using patient controlled analgesics postoperatively

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.

Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.

Outcomes

Primary Outcome Measures

Complete Response Rate
The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery

Secondary Outcome Measures

Full Information

First Posted
March 6, 2013
Last Updated
March 19, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01806948
Brief Title
Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Primary Outcome Measure Information:
Title
Complete Response Rate
Description
The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laparoscopy for benign gynecologic disease Exclusion Criteria: Vomiting within 24 hours before surgery Not using patient controlled analgesics postoperatively
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam Si
State/Province
Gyeonggi Do
ZIP/Postal Code
463707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

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