A Phase 4 interventional study of Ramosetron Hydrochloride in Postoperative Nausea and Vomiting and Breast Cancer Female, sponsored by Pusan National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Pusan National University Hospital · Phase 4, Interventional, and Prevention
The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.
The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods.
Intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 144 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Pusan National University Hospital is the lead sponsor of 78 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron
receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points
Drug: Ramosetron Hydrochloride
receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen
Drug: Ramosetron Hydrochloride
we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.
number of PONV
number of nausea, vomiting, retching
Time frame: 24hour postoperatively
number of PONV
number of nausea, vomiting, retching
Time frame: 1hour, 6hour, 48 hour postoperatively
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score
further detaied quantified in PONV experience, total score: 32, none:0, mild: 1-8 point, moderate: 9-16 point, great: 17-24 point, severe: 25-32 point
Time frame: 1hour, 6hour, 24hour, 48 hour postoperatively
Plan to share: Undecided
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Pusan National University Hospital