Modulation of General Anesthesia Using Entropy and Surgical Pleth Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Change of systolic blood pressure baseline
研究概览
简要总结
The critically ill polytrauma patient is one of the most complex cases with regard to the optimization of the intensive care, anesthesia, as well as postoperative management. One of the most important steps in the complex management of such patients is the modulation of anesthesia and the volemic resuscitation, especially in the first hours post-trauma, and in the operating room admission. We start with the assumptions that the optimization of anesthesia should depend on each patient, being conducted in an individual manner. We also believe that by individualizing the anesthesia by monitoring the entropy and SPI it is possible to obtain an appropriate management regarding resuscitation and volume replacement. Furthermore it assumes that an adequate anesthesia, and resuscitation singled volume replacement can reduce morbidity and mortality rates as well as the period of stay in the ICU and recovery time.
详细描述
Objectives
The project aims to aid to the Romanian healthcare system, by assuring new modernized monitoring equipment, specific for the department of anaesthesia and intensive care, for both clinical and paraclinical data, as well as for the existing information for modulation and optimizing of the general anaesthesia used in critically ill polytrauma cases based on modern techniques, such as entropy, and surgical pleth index (SPI). In this way, it aims to create a new prospect of developing a model, which will help the physicians in the decision-making process, hoping to improve the stats in the high morbidity and mortality rates in this specific field of medicine.
Reducing the mortality and increasing the quality of the provided medical services is possible by assuring a modern monitoring system, because critically ill patients should be observed through complex techniques. Furthermore, interpretation and timely synthesis of the biological signals and their correlation with other clinical and laboratory data are useful in modulating general anesthesia in the critically conditions.
General objectives comprise of developing a new research field regarding the international standards of research and combating the economic and social needs of Romania and Europe, by creating a complete protocol, which is innovative and helpful in improving the mortality and morbidity index for polytrauma patients admitted in the intensive care unit (ICU), by means of better monitoring procedures and modulating the anaesthesia and therapeutic management, therefore increasing the efficiency of the public health care system.
The specific objectives of the study are to represent the integration of modern anesthesia methods used for monitoring and optimizing the management of anesthesia and therapy options, depending on each patient as an individual; calculating the severity scores and risk factors, both in the first 24 hours as well as continuously, providing support instruments designed to add to the medical decision making process, and make it possible in a very short time, developing an ergonomic mode, dynamic and standardized viewing of local and distant perioperative anesthetic protocols, modulated by non-invasive modern techniques for anaesthesia monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age limit: between 18 years to 80 years;
- •gender: male and female;
- •within 2 hours of surgical intervention;
- •ASA physical status I, II, III;
- •written consent accepted to be enrolled in the study; in polytrauma patients in the operation theatre who are brought directly through the emergency department, written consent is obtained from the relatives, in accordance to the national law number 206, of 2004, for a good and correct scientific research, in the situation where the patient is no capable to sign or give the written consent;
排除标准
- •cardiac pacemaker;
- •atrial fibrillation at the time of presentation in the operation theatre;
- •any subject with epidural catheter, placed pre-operatively;
- •allergy to Propofol or another anesthetic drugs;
- •pregnancy;
- •presence of neuromuscular disease;
- •presence of neurologic disease;
结局指标
主要结局
Change of systolic blood pressure baseline
时间窗: Change from Baseline Systolic Blood Pressure at 1 hour
Evaluating the impact of general anesthesia guided with Entropy and SPI on the hemodynamic instability in the critically ill polytrauma patient; hemodynamic instability is represented and characterized by high blood pressure episodes (hypertension), or low blood pressure (hypotension).
Change of heart beat rate baseline
时间窗: Change from Baseline heart beat rate at 1 hour
Evaluating the impact of general anesthesia guided with Entropy and SPI on the heart rate in the critically ill polytrauma patient; cardiac rate instability is represented and characterized by high cardiac rate (tachycardia), or low cardiac rate (bradycardia)
Opioid consumption
时间窗: Through study completion, an average of 1 year
Evaluating the opioid consumption by general anesthesia-guided with Entropy and SPI
次要结局
未报告次要终点
研究者
Alexandru Florin Rogobete
Principal Investigator
Romanian Society of Anesthesia and Intensive Care