Population pharmacokinetics and pharmacodynamics of ramosetron

Asan Medical Center0 个研究点目标入组 51 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1) American Society of Anesthesiologists (ASA) physical status 1 or 2
•2) Age over 20
•3) Patients scheduled for elective surgery under general anesthesia
•4) Patients who volunteered
•5) Patients who have more than 2 factors of Apfel's PONV risk factor
•6) Patients scheduled for elective stomach, colorectal surgery under laparotomy or laparoscopy

•1) Age less than 20
•2) History of anaphylactic response to fentanyl, ketorolac, or ramosetron
•3) Patients who received antiemetics, steroids, antihistamines, or antipsychotic drugs that can affect PONV, within 24 hours before surgery
•4) ASA physical status over 3
•5) Patients planned for maintaning nasogastric tube postoperatively
•6) Patients with hemoglobin level less than 10.0 g/dl preoperatively
•7) Patients who participated in clinical trial on other drugs, within 30 days before screening
•8) Patients who donated blood over 450 ml, within 30 days before screening
•9) Active hepatitis (HIV postitive, history of HBV, HCV, and positive on serologic tests)
•10) Binge drinking* or clinically significant alcoholics**
•*Binge drinking: over 4 units of drinking per day ( 1 unit = 235 ml of beer, 1 glass of wine)
•**Clinically significant alcoholics: drinking pattern disrupts social life.
•11) Organ dysfuntion related to alcohol drinking.
•12) Patients conluded not appropriate, by the researcher for any other causes.

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