Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,560
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Delirium
研究概览
简要总结
The study is a prospective, double blinded, randomized and controlled parallel trial to investigate the effect of the anesthetic care guided by EEG monitor (SedLine) on postoperative delirium. EMODIPOD = Electroencephalography Monitoring tO Decrease the Incidence of PostOperative Delirium
详细描述
To investigate the impact of the anesthetic care guided by EEG monitor (SedLine) on (1) the incidence of delirium in post-anesthesia care unit (PACU) and within the first five days after laparoscopic surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients, care providers (excluding the anesthesia team taking care of the patient in the operative room), and outcome assessors are blinded to the results of randomization or group assignment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years;
- •ASA Physical Score I-III
- •Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation;
- •Extubation expected after surgery;
- •Scheduled to stay in hospital for > 3 days after surgery.
排除标准
- •Refuse to participate;
- •Emergent surgery;
- •Trauma patients;
- •Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less;
- •Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia;
- •Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment;
- •Inability to complete MMSE and delirium survey;
- •Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction < 30%, or arrhythmia with pacemaker or AICD placement;
- •Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification;
- •Severe renal dysfunction requiring renal replacement therapy before surgery;
- •Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.
研究组 & 干预措施
Study arm
All patients in the study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic "depth" management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.
干预措施: Anesthetic "depth" management (Device)
Control arm
All patients in the control arm will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.
结局指标
主要结局
Number of Participants With Postoperative Delirium
时间窗: up to five (5) days after surgery
The Number of Participants with Postoperative Delirium is operationally defined as the count of patients with postoperative delirium. Postoperative delirium is an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course.
次要结局
- Emergence Delirium(30 min following the extubation)
- Non-delirium Complications(within 30 days after surgery)
- Length of Hospital Stay(up to 30 days after surgery)
- GI Functional Recovery(within 30 days after surgery)
- ICU Admission(up to 72 hours)
- All-cause 30-day Mortality(30 days after surgery)
- Length of ICU Stay(up to 30 days after surgery)