Anesthesia, General Clinical Trial
Official title:
The Effect of Palonosetron on the QTc Interval During Perioperative Period
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 |
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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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