Study about the relationship between ramosetron dose, plasma concentration and antiemetic effect

Population pharmacokinetics and pharmacodynamics of ramosetron

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001500

Enrollment

Registered

2015-05-21

Start date

2012-10-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : After induction of anesthesia, a bolus of ramosetron either 0.3, 0.45, or 0.6 mg is injected intravenously according to randomly allocated group.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic modelling by non-comparmental analysis.;Pharmacokinetic and pharmaodynamic modelling by mixed effect model.	—

Secondary

Measure	Time frame
Analysis of relationship between CYP2D6, CYP1A1/2 gene single nucleotide polymorhpism and pharmacokinetic, pharmacodynamic characteristics.	—

Countries

Korea, Republic of

Contacts

Public ContactByungmoon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-4612

Outcome results