The Effect of Palonosetron on the QTc Interval During Perioperative Period

NCT ID: NCT01650961

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Anesthesia, General Palonosetron

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Palonosetron

Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia

Group Type EXPERIMENTAL

Palonosetron

Intervention Type DRUG

0.075 mg IV as bolus before induction of general anesthesia

Control

Intravenous administration of normal saline before the induction of general anesthesia

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

2 ml normal saline as bolus before induction of general anesthesia

Interventions

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Palonosetron

0.075 mg IV as bolus before induction of general anesthesia

Intervention Type DRUG

Normal saline

2 ml normal saline as bolus before induction of general anesthesia

Intervention Type DRUG

Other Intervention Names

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Aloxi

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24129597 (View on PubMed)

Other Identifiers

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YSJeon_palonosetron_QTc

Identifier Type: -

Identifier Source: org_study_id