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
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
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
NCT ID
NCT01806948
First Posted
March 6, 2013
Last Updated
March 19, 2016
Sponsor
Seoul National University Hospital
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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