PONV, Prolonged QTc Interval
Conditions
Keywords
ramosetron
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.
Interventions
DRUGRamosetron
Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* patients who underwent laparoscopic gynecologic surgery
Exclusion criteria
* preoperative bradyarrhythmia in ECG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QTc interval change | within 10 min after arrival at PACU, and 24 hour after discharge from PACU | Difference of QTc interval from preoperative value |
Countries
South Korea
Outcome results
None listed