Phase 4: CLINICAL EVALUATION OF TWO PHARMACOKINETICS MODELS OF PROPOFOL IN HEALTHY PEOPLE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sedation Levels
研究概览
简要总结
Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more complete published until now. Schnider was derived from 24 healhty people, and including other covariates in addition to weight, such as age, height and lean body mass though. Schnider model should not be used in obese patients. Cortínez model was derived from 20 obese patients. The differences between both models has been founded at the initial drug distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the plasma-effect equilibration time). We believe that Cortinez model also could be used in No OBESE patients because is an allometric model, and one way to evaluate and to compare both pharmacokinetics models is studying the temporary course of the effect.
The main objective of our study is to evaluate BIS and Cardiac Output values during propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion in non obese healthy volunteer.
详细描述
The study was approved by the ethics committee of the Avila Clinic. After informed consent, 10 volunteers aged 18-60 años, ASA I, Body mass Index < 30 were included.
The patients fasted for 8h before the protocol and they will not receive premedication. After arrival in the operating room, and insertion of 18-gauge intravenous cannulas placed into the forearm, a Ringer's lactate solution will be initiated. Oxygen therapy at a rate of 5 litres per minute will be administered in spontaneous ventilation. In case of hypoventilation (saturation (SaO2) <95% manual ventilation with a mask at 10 l/min of O2 will be administered. All volunteer will be monitoring with EKG, Blood pressure, Pulse Oximetry, Bispectral Index and Cardiac output.
Propofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland ). Each volunteer will be studied twice, that means which each subject then acts as their own control.
The study will make in two stages:
STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using Target Controlled Infusion device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I
- •Aged 18-60 years
- •Patients with Body mass Index < 30.
排除标准
- •Patients with Body mass Index >
- •Patients presenting psychiatric or neurological disorders , endocrine-metabolical problems, respiratory and cardiac diseases, or with allergies problems.
- •Patients who are pregnant or breastfeeding.
- •Patients treated with psychotropic drugs, including alcohol, in the 48 hours prior.
- •Patients with previous history of anesthetics complications
研究组 & 干预措施
Propofol Infusion
Propofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland )..
The study will make in two stages:
STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
干预措施: Evaluation of propofol effect (Drug)
结局指标
主要结局
Sedation Levels
时间窗: During propofol infusion period
We will use Ramsey Sedation Scale to evaluate LOC at the beginning of the infusion and after 20 minutes we will evaluate the recovery of consciousness after the infusion is stopped.
次要结局
- Bispectral index values(During a propofol infusion period)
- Hemodynamics values(During propofol infusion period)
研究者
Carolina Frederico
Anestesiologo
Tiva Group