跳至主要内容
临床试验/NCT01596387
NCT01596387已完成4 期

Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients

研究概览

简要总结

The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model to administer propofol in obese patients.

Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing weight and that mathematical models to administer drugs in obese patients can be developed to accurately predict dose schemes in this population.

详细描述

Propofol is the most frequently used IV anesthetic today. Propofol TCI is commonly used for induction and maintenance of general anaesthesia in obese and non obese patients. However, current propofol PK models, used in TCI devices, were derived from studies that did not include obese patients. A controversial issue for propofol dose adjustment in this population has been the selection of an adequate size descriptor to scale PK parameters, as drug administration based on total body weight can result in overdose, and conversely, administration based on ideal body weight can result in a sub-therapeutic dose. In a previous study from our group, we developed a PK model capable of characterizing the influence of obesity on propofol disposition. The purpose of this study is to validate this model to administer propofol in obese patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • IMC > 35 kg m-2
  • Scheduled for laparoscopic bariatric surgery
  • ASA I-II patients
  • Between 18 and 60 yr of age.

排除标准

  • Patients with allergy to study drugs
  • Uncontrolled hypertension
  • Heart block greater than first degree
  • Take any drug acting in the central nervous system within 24 hrs before surgery.

研究组 & 干预措施

Propofol

Experimental

20 obese patients(IMC>35 kg m-2) scheduled for laparoscopic bariatric surgery.

干预措施: Propofol (Drug)

结局指标

主要结局

Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients

时间窗: During the intraoperative period and until 120 min after stopping propofol infusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignacio Cortínez F.

Profesor Asociado, Departamento de Anestesiología

Pontificia Universidad Catolica de Chile

研究点 (1)

Loading locations...

相似试验