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Completed

NCT Number: NCT01650961

The Effect of Palonosetron on the QTc Interval During Perioperative Period

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

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Key information

Conditions

Anesthesia, General Palonosetron

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron

Drug

0.075 mg IV as bolus before induction of general anesthesia

Other names: Aloxi

normal saline

Drug

2 ml normal saline as bolus before induction of general anesthesia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 26, 2012
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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