A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly Patients After Urological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium within 7 days after surgery.
研究概览
简要总结
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex).Observation contents: Whether there is postoperative delirium and its severity: 3D - CAM assessment scale, DMAS assessment scale; awakening time, extubation time, PACU stay time, hospital stay time; 1 - 7 days after surgery or before discharge, POD assessment and pain - sleep assessment, the first time getting out of bed; postoperative complications; adverse reactions; adverse events, and so on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age ≥ 60 years old; (2) Patients scheduled for elective urological surgery under general anesthesia with tracheal intubation; (3) ASA classification I - III; (4) Estimated operation duration ≥ 2 hours; (5) Informed consent from the patient or their guardian; (6) Proficient in communicating in Chinese. -
排除标准
- •(1) Patients with permanent lack of autonomy (2) Not applicable for delirium assessment: including language disorders, deafness, blindness or aphasia, coma (3) With treatment abandonment or brain death (4) Known pregnancy or lactation (5) Unable to obtain consent according to national regulations (6) Patients forcibly hospitalized by regulatory authorities (compulsory measures) (7) With cardiac pacemaker or stent implantation (8) Patients with delirium (9) Patients with known brain lesions (10) Patients with known epilepsy history, having taken drugs that can cause epileptic seizures, having metal implants in the neck or brain, or having cerebral hemorrhage ，Acute phase, acute infectious diseases (11) Habitual treatment with antipsychotic drugs (12) Received antipsychotic drug treatment in the ICU before enrollment (13) Patients with severe liver dysfunction (Child-Pugh C grade) (14) Patients with severe kidney dysfunction (requiring dialysis before surgery) (15) Severe heart failure (METS < 4) (16) Preoperative cognitive impairment as determined by a MoCA evaluation prior to surgery;
研究组 & 干预措施
Perform transcranial magnetic stimulation on elderly patients undergoing urological surgery
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex)
干预措施: Transcranial Magnetic Stimulation Device (Device)
结局指标
主要结局
Incidence of postoperative delirium within 7 days after surgery.
时间窗: From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon
In the anesthesia recovery room, the CAM-ICU(The Confusion Assessment method for the ICU ) scale was performed 30 min after extubation. Postoperative delirium was measured by the 3D-CAM (The 3-Minute Diagnostic Confusion Assessment Method)scale from postoperative day 1 until postoperative day 7 or before discharge from the hospital. The CAM scale includes four major features: 1. Acute onset or fluctuating changes in condition 2. Inattention 3. Confusion 4. Changes in level of consciousness. Delirium is diagnosed when features 1 and 2 are positive at the same time, and/or features 3 and 4 are positive.
次要结局
- The severity of postoperative delirium(From the day of surgery to 7 days after surgery)
研究者
Diansan Su
Chair of the Department of Anesthesiology
Zhejiang University