Ramosetron Pre-treatment for PONV and QT Prolongation

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.

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Key information

Conditions

PONV Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Prolonged QTc Interval Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

19 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lee Sung Ho

Seoul, 05030, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who underwent laparoscopic gynecologic surgery

Exclusion criteria

preoperative bradyarrhythmia in ECG

Treatment and study plan

Ramosetron

Drug

Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery

Other names: ramosetron pre-treatment

Primary outcomes

QTc interval change

Time frame: within 10 min after arrival at PACU, and 24 hour after discharge from PACU

Difference of QTc interval from preoperative value

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Sep 11, 2017
Registry last updated: Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed