The Effect of Palonosetron on the QTc Interval During Perioperative Period

August 6, 2013 updated by: Seoul National University Hospital
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Palonosetron
Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia
Drug: Palonosetron
0.075 mg IV as bolus before induction of general anesthesia
Other Names:
  • Aloxi
PLACEBO_COMPARATOR: Control
Intravenous administration of normal saline before the induction of general anesthesia
Drug: Normal saline
2 ml normal saline as bolus before induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corrected QT interval (QTc interval)
Time Frame: 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
up to 90 minutes after induction of general anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female
Time Frame: up to 2 hours after induction of general anesthesia
up to 2 hours after induction of general anesthesia
corrected QT interval (QTc interval) at Postanesthetic care unit
Time Frame: up to 1 hour after arrival on postanesthetic care unit
up to 1 hour after arrival on postanesthetic care unit
Incidence of postoperative nausea and vomiting
Time Frame: for 24 hours after surgery
for 24 hours after surgery
proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)
Time Frame: up to 2 hours after induction of general anesthesia
up to 2 hours after induction of general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (ESTIMATE)

July 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YSJeon_palonosetron_QTc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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