Ramosetron Pre-treatment for PONV and QT Prolongation

Konkuk University Medical Center

Status and phase: Completed; Phase 4

Conditions: PONV; Prolonged QTc Interval

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT03278522

KUH1160112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who underwent laparoscopic gynecologic surgery

Exclusion criteria

• preoperative bradyarrhythmia in ECG

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 2 patient groups

ramosetron iv at induction (I)

Active Comparator group

Description:

0.6mg of ramosetron is given to the patients intravenously at anesthesia induction

Treatment:

Drug: Ramosetron

ramosetron iv at recovery (R)

Active Comparator group

Description:

0.6mg of ramosetron is given to the patients intravenously at end of surgery

Treatment:

Drug: Ramosetron