Completed
Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting
What is being tested
Ramosetron
+ Ramosetron
Drug
Who is being recruted
Nausea+5
+ Pathologic Processes
+ Postoperative Complications
+3 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-ControlledPhase 2
Interventional
Study Start: April 2013
Summary
Principal SponsorSeoul National University Hospital
Last updated: March 22, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorSeoul National University Hospital
Last updated: March 22, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
NauseaPathologic ProcessesPostoperative ComplicationsSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsVomitingPostoperative Nausea and Vomiting
Criteria
1 inclusion criteria required to participate
Laparoscopy for benign gynecologic disease
2 exclusion criteria prevent from participating
Not using patient controlled analgesics postoperatively
Vomiting within 24 hours before surgery
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboSingle 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.
Group II
ExperimentalDouble 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.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Seoul National University Bundang Hospital
Seongnam-si, South KoreaOpen Seoul National University Bundang Hospital in Google MapsCompletedOne Study Center