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
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.
Exclusion Criteria:
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.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Postoperative Nausea and Vomiting→
Konkuk University Medical Center