Study about the relationship between ramosetron dose, plasma concentration and antiemetic effect
- Conditions
- Not Applicable
- Registration Number
- KCT0001500
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 51
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic modelling by non-comparmental analysis.;Pharmacokinetic and pharmaodynamic modelling by mixed effect model.
- Secondary Outcome Measures
Name Time Method Analysis of relationship between CYP2D6, CYP1A1/2 gene single nucleotide polymorhpism and pharmacokinetic, pharmacodynamic characteristics.