The Effect of Palonosetron on the QTc Interval During Perioperative Period

Not Applicable

Completed

• Conditions: Anesthesia, General; Palonosetron
• Interventions: Drug: Normal saline; Drug: Palonosetron

• Registration Number: NCT01650961
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	Intravenous administration of normal saline before the induction of general anesthesia
Palonosetron	Palonosetron	Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
corrected QT interval (QTc interval)	up to 90 minutes after induction of general anesthesia	at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation

Secondary Outcome Measures

Name	Time	Method
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
corrected QT interval (QTc interval) at Postanesthetic care unit	up to 1 hour after arrival on postanesthetic care unit
Incidence of postoperative nausea and vomiting	for 24 hours after surgery
proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)	up to 2 hours after induction of general anesthesia

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of