Ramosetron Pre-treatment for PONV and QT Prolongation
- Registration Number
- NCT03278522
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 64
- patients who underwent laparoscopic gynecologic surgery
- preoperative bradyarrhythmia in ECG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ramosetron iv at induction (I) Ramosetron 0.6mg of ramosetron is given to the patients intravenously at anesthesia induction ramosetron iv at recovery (R) Ramosetron 0.6mg of ramosetron is given to the patients intravenously at end of surgery
- Primary Outcome Measures
Name Time Method QTc interval change within 10 min after arrival at PACU, and 24 hour after discharge from PACU Difference of QTc interval from preoperative value
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lee Sung Ho
🇰🇷Seoul, Korea, Republic of