Population analysis of ramosetron for postoperative nausea and vomiting
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
Ramosetron is a selective serotonergic 5-hydroxy-tryptamine receptor 3 antagonist that is used to prevent and treat postoperative nausea and vomiting. This study aimed to characterize the population pharmacokinetics of ramosetron in patients undergoing surgery with general anesthesia. Patients aged 19–80 years received a single intravenous bolus of ramosetron (0.3, 0.45, or 0.6 mg) 30 min before the end of surgery. Blood samples were collected, and plasma concentrations of ramosetron were measured by high performance liquid chromatography-tandem mass spectrometry. Pooled data from 50 patients and 479 pharmacokinetic samples were used for population pharmacokinetic analysis using the nonlinear mixed effect modeling program (NONMEM®). The pharmacokinetics of ramosetron was best described by a three-compartment mammillary model with first-order elimination. Based on allometric principles, body weight was incorporated in the base model, along with fixed allometric exponents. The typical value of clearance was 0.19 L/h in a 60-kg subject, and it decreased approximately 3 % for every year of age, starting at age of 57. The bootstrap method and visual predictive check showed that the final pharmacokinetic model was appropriate. A population pharmacokinetic model of ramosetron was constructed in adult surgical patients, providing a foundation for further defining the relationship between ramosetron dose and postoperative nausea and vomiting.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •.American Society of Anesthesiology Physical status classification is 1 or 2 patients.
- •.19 years of age or over
- •.Surgery under elective general anesthesia.
- •.Patients signed up the voluntary written consent to participate in clinical studies.
- •.Apfel's Postoperative nausea and vomiting risk score is 3 or more.
排除标准
- •.Under nineteen years of age
- •.Patients with known hypersensitivity for fentanyl, ketorolac or test drug(Ramosetron).
- •.Medications within 24 hours before surgery have potentials affecting the postoperative nausea and vomiting such as antiemetics, steroids, antihistamines,or psychotropic drugs.
- •.American Society of Anesthesiology Physical status classification is 3 or more patients.
- •.Patients go through nasogastric tube after surgery,
- •.Hemoglobin is less than 10.0g/dL.
- •.Patients participated in a screening of another clinical trial of medication within 30days.
- •.Patients donate more than 450ml blood or blood products within 30days.
- •.Patients with active hepatitis
- •.Heavy aldohol drinker or clinical significant findings in patients with alcoholism
- •.Patients with organ dysfunction or history associated with alcohol.
- •.Besides the above all, investigators have determined that the patient is not appropriate.