The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery

Seoul National University

Status: Completed

Conditions: Hypotension; Coronary Artery Bypass Graft Triple Vessel

Treatments: Drug: Normal saline; Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02139241

Ramosetron_opcab

Details and patient eligibility

About

The purpose of this study is to assess the effects of ramosetron on corrected QT interval in patients undergoing off pump coronary artery bypass surgery.

Enrollment: 114 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective off-pump coronary artery bypass graft surgery

Exclusion criteria

• Emergency operation
• preoperative use of any inotropics or mechanical assist device
• severe liver disease (>Child class II)
• dialysis dependent renal failure
• Left ventricular ejection fraction <30 %
• Combined major surgery like carotid endarterectomy
• Previous allergy history to any 5-hydroxytryptamine type 3 (5-HT3) antagonist
• Preoperative QT prolongation ( 500 >msec) or arrhythmia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

114 participants in 2 patient groups, including a placebo group

Ramosetron

Experimental group

Description:

Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia

Treatment:

Drug: Ramosetron

Control

Placebo Comparator group

Description:

Intravenous administration of 2ml normal saline before the induction of general anesthesia

Treatment:

Drug: Normal saline