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The Effect of Palonosetron on the QTc Interval During Perioperative Period

This study is currently recruiting participants.
Verified February 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01650961
First received: July 24, 2012
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Anesthesia, General
Palonosetron
 Drug: Palonosetron
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Palonosetron on the QTc Interval During Perioperative Period

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • corrected QT interval (QTc interval) [ Time Frame: up to 90 minutes after induction of general anesthesia ] [ Designated as safety issue: Yes ]
    at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • corrected QT interval (QTc interval) at Postanesthetic care unit [ Time Frame: up to 1 hour after arrival on postanesthetic care unit ] [ Designated as safety issue: Yes ]
  • Incidence of postoperative nausea and vomiting [ Time Frame: for 24 hours after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650961

Contacts
Contact: Yunseok Jeon, PhD 82-2-2072-2467 jeonyunseok@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yunseok Jeon     82-2-2072-2467     jeonyunseok@gmail.com    
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01650961     History of Changes
Other Study ID Numbers: YSJeon_palonosetron_QTc
Study First Received: July 24, 2012
Last Updated: February 4, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013