A Phase 4 interventional study of Ramosetron in PONV and Prolonged QTc Interval, sponsored by Konkuk University Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Prevention
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Among 15 studies testing ramosetron in Postoperative Nausea and Vomiting — none open to participants now, none under way, none of them phase 3. ramosetron · Postoperative Nausea and Vomiting.
Among the 15 studies testing ramosetron in Postoperative Nausea and Vomiting, this one is the 13th largest by enrollment, is the only one that started in 2017, is one of 7 in phase 4, and was the 14th registered.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
Browse Postoperative Nausea and Vomiting studies →None of the 15 studies testing ramosetron in Postoperative Nausea and Vomiting is open now. The open studies under Postoperative Nausea and Vomiting, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 65 Postoperative Nausea and Vomiting studies recruiting now, 22 (34%) set no upper age limit and 37 (57%) stop at 75 or younger; 14 take children under 18; 11 take healthy volunteers.
This study: 19 Years to 99 Years · female · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 64 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Median enrollment 100 across the 15 interventional studies. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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None of the 15 has an industry lead sponsor. The 10 most frequent:
Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Konkuk University Medical Center has 3 studies filed under Postoperative Nausea and Vomiting — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing ramosetron in Postoperative Nausea and Vomiting, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.
This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU.
Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.6mg of ramosetron is given to the patients intravenously at anesthesia induction
Drug: Ramosetron
0.6mg of ramosetron is given to the patients intravenously at end of surgery
Drug: Ramosetron
Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery
Also known as: ramosetron pre-treatment
QTc interval change
Difference of QTc interval from preoperative value
Time frame: within 10 min after arrival at PACU, and 24 hour after discharge from PACU
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Feb 2018, 7 months.
Of 67 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 7 months is below that.
Counting every sponsor, half of 67 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ramosetron
Postoperative Nausea and Vomiting →
Konkuk University Medical Center