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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650961
Other study ID # YSJeon_palonosetron_QTc
Secondary ID
Status Completed
Phase N/A
First received July 24, 2012
Last updated August 6, 2013
Start date July 2012
Est. completion date February 2013

Study information

Verified date August 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Palonosetron
0.075 mg IV as bolus before induction of general anesthesia
Normal saline
2 ml normal saline as bolus before induction of general anesthesia

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
Secondary corrected QT interval (QTc interval) at Postanesthetic care unit up to 1 hour after arrival on postanesthetic care unit Yes
Secondary Incidence of postoperative nausea and vomiting for 24 hours after surgery No
Secondary proportion of patients who have more than 500 ms of corrected QT interval (QTc interval) up to 2 hours after induction of general anesthesia Yes
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