The Effect of Palonosetron on the QTc Interval During Perioperative Period

Anesthesia, General Clinical Trial

Official title:

The Effect of Palonosetron on the QTc Interval During Perioperative Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650961
• Other study ID #: YSJeon_palonosetron_QTc
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: August 6, 2013
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• 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 palonosetron on corrected QT interval duration during and after general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Elective abdominal surgery under general anesthesia

Exclusion Criteria:

• Cardiac valvular disease

• Clinically significant arrhythmias including atrial fibrillation

• Anti-emetics within 24 hours before surgery

• Steroids within 1 week before surgery

• Cancer chemotherapy or radiotherapy within 4 weeks before surgery

• Diabetes mellitus

• Pregnancy

• Patients receives a QT-prolonging drug

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

• Anesthesia, General
• Palonosetron

Intervention

Drug:
• Palonosetron
0.075 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corrected QT interval (QTc interval)	at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation	up to 90 minutes after induction of general anesthesia	Yes
Secondary	proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female		up to 2 hours after induction of general anesthesia	Yes
Secondary	corrected QT interval (QTc interval) at Postanesthetic care unit		up to 1 hour after arrival on postanesthetic care unit	Yes
Secondary	Incidence of postoperative nausea and vomiting		for 24 hours after surgery	No
Secondary	proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)		up to 2 hours after induction of general anesthesia	Yes