Anesthesia, General, Palonosetron
Conditions
Brief summary
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.
Interventions
DRUGPalonosetron
0.075 mg IV as bolus before induction of general anesthesia
DRUGNormal saline
2 ml normal saline as bolus before induction of general anesthesia
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| corrected QT interval (QTc interval) | 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
| Measure | Time frame |
|---|---|
| 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 |
| corrected QT interval (QTc interval) at Postanesthetic care unit | up to 1 hour after arrival on postanesthetic care unit |
| Incidence of postoperative nausea and vomiting | for 24 hours after surgery |
| proportion of patients who have more than 500 ms of corrected QT interval (QTc interval) | up to 2 hours after induction of general anesthesia |
Countries
South Korea
Outcome results
None listed