Randomized Controlled Trial for Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia (TIVA) Using Propofol and Remifentanil
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Registration of pain monitor output during surgery under general anesthesia
研究概览
简要总结
The randomized controlled trial study aims to validate a new pain monitor during general anesthesia by comparing the new ANSPEC-PRO monitor (non-CE marked) with already CE-marked pain monitors (Medstorm and Medasense). One hundred and eighty patients will be randomized into six groups, wherein each group has 30 patients. Patients preparing for a surgical operation under general anesthesia will be included to be monitored for pain during surgery procedure, while the standard monitoring, medication, and standard care will not be disturbed.
Pain monitoring is done with the ANSPEC-PRO, MEDASENSE, or MEDSTORM in the operation room, before and during general anesthesia: the pain monitor will record data continuously, while the following will be recorded in parallel: blood pressure, heart rate, saturation, CO2, O2 end-tidal concentrations, electromyogram, signal quality, the given amount of analgesics and hypnotics, and TOF (train-of-four).
详细描述
Primary Objective: Validation of ANSPEC-PRO as pain monitor during general anesthesia.
Secondary Objectives
- Evaluation of quality of monitoring ANSPEC-PRO compared with other pain monitors (Medasense and Medstorm);
- Evaluation of the correlation between measurements of pain monitors (ANSPEC-PRO, Medstorm and Medasense) and the level of analgesia represented as TCI infusion of Remifentanil;
- To determine the most suitable device for the development of a MIMO pharmacodynamic interaction model of Propofol and Remifentanil for use in closed- loop drug-delivery systems for anesthesia;
- Evaluation of the interaction between analgesics and hypnotics measured by ANSPEC-PRO and BIS/Neurowave.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
The results of the pain monitors are masked for the investigator
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years and younger than 80 years
- •Patients able to comprehend, sign, and date the written informed consent document to participate in the clinical trial.
- •ASA Class I, II, III classified by the anesthesiologist.
- •Patients planned for a surgical procedure under general anesthesia.
排除标准
- •Patients having epidural analgesia infused by a pain pump during the operation.
- •Patients with chronic pain or getting medication used for chronic pain, like anti-epileptics, antidepressants, opioids.
- •Pregnant women (asked at the patient before the operation)
- •Patients with electrically sensitive life support systems (e.g. implanted pacemaker, defibrillator)
研究组 & 干预措施
non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor
non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor: the monitoring will be done in different periods. In each period the two monitors will monitoring the pain in a serial way. Period 1: awake patient, Period 2: sedated patient with propofol, Period 3 : monitoring during standardized pain stimulus; Period 4: monitoring during surgery
干预措施: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor (Device)
non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor
non invasive analgesia monitoring with ANSPEC-PRO and MEDSTORM the monitoring will be done in different periods. In each period the two monitors will monitoring the pain in a serial way. Period 1: awake patient, Period 2: sedated patient with propofol, Period 3 : monitoring during standardized pain stimulus; Period 4: monitoring during surgery
干预措施: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor (Device)
non-invasive analgesia monitoring with MEDSTORM and MEDASENSE
non-invasive analgesia monitoring with MEDSTORM and MEDASENSE the monitoring will be done in different periods. In each period the two monitors will monitoring the pain in a serial way. Period 1: awake patient, Period 2: sedated patient with propofol, Period 3 : monitoring during standardized pain stimulus; Period 4: monitoring during surgery
干预措施: Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor (Device)
结局指标
主要结局
Registration of pain monitor output during surgery under general anesthesia
时间窗: during general anesthesia for surgery
validation of the pain monitor during aensthesia
次要结局
未报告次要终点