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NCT03278522 Clinical Trial

Ramosetron Pre-treatment for PONV and QT Prolongation

PONV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03278522
Other study ID # KUH1160112
Secondary ID
Status Completed
Phase Phase 4
First received September 6, 2017
Last updated March 7, 2018
Start date July 1, 2017
Est. completion date February 28, 2018

Study information
Verified date March 2018
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 64
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 99 Years
Eligibility Inclusion Criteria:

- patients who underwent laparoscopic gynecologic surgery

Exclusion Criteria:

- preoperative bradyarrhythmia in ECG

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Lee Sung Ho Seoul

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary QTc interval change Difference of QTc interval from preoperative value within 10 min after arrival at PACU, and 24 hour after discharge from PACU
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