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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139241
• Other study ID #: Ramosetron_opcab
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: November 17, 2015
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Triple Vessel
• Hypotension

Intervention

Drug:
• Ramosetron
0.3 mg IV as bolus before induction of general anesthesia
• Normal saline
2 ml normal saline as bolus before induction of general anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Havrilla PL, Kane-Gill SL, Verrico MM, Seybert AL, Reis SE. Coronary vasospasm and atrial fibrillation associated with ondansetron therapy. Ann Pharmacother. 2009 Mar;43(3):532-6. doi: 10.1345/aph.1L544. Epub 2009 Mar 3. — View Citation

Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corrected QT interval (QTc interval)	at 1,2,3,5,10,15,30,45,60,90,120,240 minutes after ramosetron injection, at the time of operation end, ICU 12hour	up to 240 minutes after induction of general anesthesia	Yes
Secondary	hypotension or bradycardia during the peri-induction period and the coronary anastomosis period		up to 240 minutes after induction of general anesthesia	Yes
Secondary	incidence of postoperative atrial fibrillation		during the hospital stay (from ICU admission to hospital discharge, average of 1 week)	Yes