Population analysis of palonosetron

Population analysis of palonosetron for postoperative nausea and vomiting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001254

Enrollment

Registered

2014-10-14

Start date

2014-02-09

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 : palonosetron 0.075, 0.15, 0.225mg bolus intravenous injection just before surgery according to the group.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.American Society of Anesthesiology Physical status classification is 1 or 2 patients. 2.19 years of age or over 3.Surgery under elective general anesthesia. 4.Patients signed up the voluntary written consent to participate in clinical studies. 5.Apfel's Postoperative nausea and vomiting risk score is 3 or more.

Exclusion criteria

Exclusion criteria: 1.Under nineteen years of age. 2.Patients with known hypersensitivity for fentanyl, ketorolac or test drug (Palonosetron). 3.Medications within 24 hours before surgery have potentials affecting the postoperative nausea and vomiting such as antiemetics, steroids, antihistamines, or psychotropic drugs. 4.American Society of Anesthesiology Physical status classification is 3 or more patients. 5.Patients go through nasogastric tube after surgery, 6.Hemoglobin is less than 10g/dl. 7.Patients participated in a screening of another clinical trial of medication within 30days. 8.Patients donate more than 450ml blood or blood products within 30days. 9.Patients with active hepatitis 10.Heavy alcohol drinker or clinical significant findings in patients with alcoholism. 11.Patients with organ dysfuntion or history associated with alcohol. 12.Besides the above all, investigators have determined that the patient is not appropriate.

Design outcomes

Primary

Measure	Time frame
Non-compartment pharmacokinetic analysis;Populational pharmacokinetic analysis with Nonlinear Mixed Effect modeling VII level 3;Poplational pharmacodynamic analysis with Nonlinear Mixed Effect modeling VII level 3	—

Secondary

Measure	Time frame
collection and reporting of all adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactSeongwook Jeong

Chonnam National University Hospital Hwasun Hospital

anesman@gmail.com+82-61-379-8546

Outcome results