NCT03278522

Ramosetron Pre-treatment for PONV and QT Prolongation

Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: Female
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PONV
• Prolonged QTc Interval

Interventions

Type	Name	Description
DRUG	Ramosetron	Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-09-11
• Last updated: 2018-03-09

Locations

1 site across 1 country: South Korea