An Investigation of the Impact of Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring on the Clinical Outcomes of Patients Undergoing Thoracic Surgery: A Factorial Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Rate of in-hospital postoperative pulmonary complications
研究概览
简要总结
Patients undergoing thoracotomy in thoracic surgery are prone to have complications of delayed recovery from general anesthesia and perioperative instable hemodynamics due to the relatively invasive procedures and patient's underlying morbidity. Therefore, intraoperative monitoring and corresponding management are of great importance to prevent relevant complications in thoracic surgery. This study aims to investigate the clinical benefits of two intraoperative monitoring techniques in patients undergoing thoracotomy surgery, including depth of anesthesia and minimally invasive cardiac output monitoring. First, M-Entropy system will be used to measure the depth of anesthesia and be evaluated regarding the effect of spectral entropy guidance on postoperative recovery. Second, we will apply ProAQT device in guiding goal-directed hemodynamic therapy and assess its impact on occurrence of postoperative pulmonary complications and recovery. In this study, we will conduct a factorial parallel randomized controlled trial and use the method of stratified randomization to evaluate both two monitoring technologies in the same patient group. The results of this study will provide important evidence and clinical implication for precision anesthesia and enhanced recovery after surgery (ERAS) protocol in thoracic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.
排除标准
- •Age < 20 years
- •Pregnancy
- •End-stage renal disease
- •Emergency surgery
- •Presence of circulatory shock needing vasoactive drugs before surgery
- •Any diagnosis of aortic diseases
- •Cerebral vascular diseases or trauma
- •High-degree cardiac arrythmia (e.g. atrial fibrillation)
- •Uses of cardiac pacemaker or automated implantable cardioverter defibrillator
- •New York Heart Association functional classification 4
- •Long-term use of psychiatric medications
- •Intraoperative blood loss > 1 L
- •Intraoperative blood transfusion
- •Planned or unanticipated transferal to ICU for postoperative mechanical ventilation
- •Patient refusal to participate
结局指标
主要结局
Rate of in-hospital postoperative pulmonary complications
时间窗: Within 30 days after surgery
This includes atelectasis, pleural effusion, pneumonia, empyema, pulmonary embolism, re-operation, and respiratory failure. The diagnosis of atelectasis and pleural effusion will be made based on routinely performed chest radiographs on postoperative days 1 and 3. Pneumonia will be diagnosed if a patient presents with fever, leukocytosis and new infiltrates on chest radiography. Pleural empyema and pulmonary embolism will be confirmed by spiral computed tomography scan. Respiratory failure is defined as described in the protocol.
Time to spontaneous eye opening
时间窗: At the end of surgery
The interval from the cessation of anesthetics to spontaneous eye opening
次要结局
- Time to tracheal extubation(At the end of surgery)
- Time to orientation in time and place(At the end of surgery)
- Arterial partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2)(After induction of anesthesia and at the end of surgery)
- Time to leave operating room(At the end of surgery)
- Rate of emergence agitation(During the recovery from anesthesia)
- Rate of postoperative delirium(30 minutes after tracheal extubation)
- Rate of intraoperative recall or awareness(One day after surgery)
- Rate of cardiac complications(Within 30 days after surgery)
- Rate of newly developed stroke(Within 30 days after surgery)
- Rate of hypotensive episodes(Within 30 days after surgery)
- Length of hospital stay(Within 30 days after surgery)
研究者
YingHsuanTai
Department of Anesthesiology
Taipei Medical University Shuang Ho Hospital