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The Effect of Palonosetron on the QTc Interval During Perioperative Period

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ClinicalTrials.gov Identifier: NCT01650961
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Palonosetron Drug: Palonosetron Drug: Normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Palonosetron on the QTc Interval During Perioperative Period
Study Start Date : July 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. corrected QT interval (QTc interval) at Postanesthetic care unit [ Time Frame: up to 1 hour after arrival on postanesthetic care unit ]
  3. Incidence of postoperative nausea and vomiting [ Time Frame: for 24 hours after surgery ]
  4. 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650961


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01650961     History of Changes
Other Study ID Numbers: YSJeon_palonosetron_QTc
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Anesthetics
Palonosetron
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action