Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adequacy of anesthesia
研究概览
简要总结
Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of Entropy.In this study we performed a randomized, controlled, study to compare closed-loop control and open-loop control of propofol by using the Entropy and SPI guided closed-loop infusion system.
详细描述
Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total intravenous anesthesia is more effective to maintain depth of anesthesia compared with target controlled infusion with open systems, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for hypnotic is better than the controlled algorithm based pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of Anesthesia depth.
The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI for administration of intravenous anesthesia using adequacy of anesthesia monitoring to maintain a depth of anesthesia compared to an open loop system TCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years
- •Scheduled for noncardiac surgery elective low-risk or intermediate risk. -Expected surgery time greater than 1 hour
- •Procedure requiring general anesthesia
- •Classification of the American Society of Anesthesiologists (ASA) as I,II, lll
排除标准
- •Pregnant women
- •Surgery scheduled urgent or emergency
- •Personal history of allergy to eggs or any other part of propofol
- •Personal history of abnormalities or congenital or acquired cognitive sequels: infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism.
- •Chronic use of benzodiazepines or antipsychotics
- •A patient who does not consent to participate in the study prior to surgery or before randomization
- •Need for anesthetic or analgesic blockade before surgery peripheral nerve
研究组 & 干预措施
Closed-Loop propofol Target control infusion
Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI
干预措施: Closed-Loop propofol Target controlled infusion by Entropy and SPI (Device)
Open-loop propofol target control infusion
Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm
干预措施: Open-loop propofol target controlled infusion (Device)
结局指标
主要结局
Adequacy of anesthesia
时间窗: 1 day
Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Spatial entropy in the range of 40 - 60 during a surgery.
Time taken for recovery from Anesthesia
时间窗: 1 day
Total time taken for recovery after stopping of infusion
次要结局
- Total consumption of propofol(1 day)
- Number of hypotension events(1 day)
研究者
Shivakumar M C, MD
Professor and HEAD, Department of Anesthesiologist and critical care medicine
KVG Medical College and Hospital