The Effect of Palonosetron on the QTc Interval During Perioperative Period
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 7, 2013
August 1, 2013
5 months
July 24, 2012
August 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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
Study Arms (2)
Palonosetron
EXPERIMENTALIntravenous administration of palonosetron 0.075 mg before the induction of general anesthesia
Control
PLACEBO COMPARATORIntravenous administration of normal saline before the induction of general anesthesia
Interventions
0.075 mg IV as bolus before induction of general anesthesia
Eligibility Criteria
You may qualify if:
- Elective abdominal surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014 Mar;112(3):460-8. doi: 10.1093/bja/aet335. Epub 2013 Oct 14.
PMID: 24129597DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 26, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
August 7, 2013
Record last verified: 2013-08