Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Depth of Hypnosis (WAVcns)
研究概览
简要总结
In closed-loop controlled anesthesia, feedback from a measure of the clinical effect is used to continuously adjust drug infusion rates. Anesthetic drugs are delivered at a variable rate that is personalized to the individual patient. The aim is to provide greater hemodynamic and respiratory stability, more stable depth of anesthesia, the ability to predict recovery and to administer a lower total dose of drug. Previous work in closed-loop control of intravenous anesthesia has focused on the titration of propofol in response to a depth of hypnosis (DOH) measure derived from the electroencephalogram (EEG).
The purpose of this pilot study is to evaluate iControl-RP, a system, which performs controlled delivery of both remifentanil and propofol infusions. iControl-RP allows either drug to be operated in any of 3 modes: closed-loop control based on feedback from an EEG measure supplied by NeuroSENSE (1); target-controlled infusion (TCI), based on previously-described pharmacokinetic (PK) and pharmacodynamic (PD) models; and conventional manual infusion, which require a weight-based dose setting.
A pilot two-phase study will be undertaken in a group of adult patients under the direct and immediate supervision of an experienced anesthesiologist. In Phase 1 (involving 50 study subjects), propofol will be administered in closed-loop mode and a remifentanil infusion will be administered based on a TCI. The data collected in this phase will be used to tune the controller parameters, which are initially based on previously published PKPD data. The controller performance will then be evaluated in phase 2 (involving 100 study subjects), in which both propofol and remifentanil will be administered in closed loop mode. In both phases, cases will be selected from those receiving propofol and remifentanil as anesthetic agents for routine surgical procedures.
The investigators aim to demonstrate that closed-loop control of anesthesia and analgesia based on EEG feedback is clinically feasible. This pilot study will help us take a significant step towards a controlled trial in which the clinical benefit of this method of closed-loop control of anesthesia can be assessed.
详细描述
Purpose:
The purpose of this pilot study is to demonstrate that controlled delivery of remifentanil and propofol is clinically feasible and to collect a sample of clinical data to optimise the control functions. That is,
to demonstrate that the iControl remifentanil-propofol control system (iControl-RP) can be used to provide safe and effective administration of anesthesia (while maintaining the requirement for intervention by the anaesthesiologist when necessary) to collect a sample of clinical data that will allow the ECEM engineers to optimise the parameters of the iControl-RP control system
Justification:
Closed-loop control provides an opportunity to deliver anesthetic drugs at variable rate that is personalized to the individual patient. This suggests that it may provide greater hemodynamic and respiratory stability, more stable depth of anesthesia, the ability to predict recovery and to administer a lower total dose of drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •ASA I-III
- •Elective surgical procedures performed in the operating room at Royal Columbian Hospital requiring TIVA
- •Ability to provide informed consent
排除标准
- •Contra-indications to the administration of propofol and/or remifentanil:
- •propofol is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products; remifentanil is contraindicated in patients with known hypersensitivity to fentanyl analogs.
- •Known or suspected neurological disease
- •Known abnormality in any previous EEG examination
- •Chronic opioid analgesic (more than 10 doses in previous one month) or other sedative drug therapy
- •Body Mass Index (BMI) < 15 or BMI > 45
- •Premedication other than metoclopramide and/or ranitidine required
- •Currently enrolled in another drug or device clinical trial
结局指标
主要结局
Depth of Hypnosis (WAVcns)
时间窗: Continually assessed throughout anesthesia
Depth of hypnosis measurements will be used among other parameters to assess the feasibility of the system for delivery of propofol and remifentanil for anesthesia
次要结局
- Time until induction complete (Tind)(Beginning of anesthesia)