The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 主要终点
- The incidence of PND on the postoperative day 30
研究概览
简要总结
To investigate the impact of rTMS on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. To explore the underlying mechanisms behind the efficacy.
详细描述
There is a relatively high incidence of perioperative neurocognitive disorders（PND） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. Nevertheless, there remains no effective medication or intervention been approved in PND. It has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. However, the effects on cognitive function in PND remain uninvestigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 18 years or older.
- •ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
- •Sign the informed consent.
- •Able to complete follow-up visits.
排除标准
- •A history of psychopathology and/or taking medication.
- •Previous history of neurological disease.
- •Severe organic diseases.
- •RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
- •Having delirium, assessed by CAM, before surgery.
- •Participating in other clinical studies at the time of screening.
- •Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
- •Having short-term second operation.
研究组 & 干预措施
Active rTMS Group
A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.
干预措施: repetitive transcranial magnetic stimulation (Procedure)
Sham Stimulation Group
Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.
干预措施: Sham Stimulation (Procedure)
结局指标
主要结局
The incidence of PND on the postoperative day 30
时间窗: Within 30 days after surgery
Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.
次要结局
- Perioperative pain(Within 7 days after surgery)
- Postoperative delirium incidence(Within 7 days after surgery)
- Sleep quality(Within 30 days after surgery)
- Depressive symptom(Within 7 days after surgery)
- Length of hospital stay(From the date of admission until discharged from hospital, up to 30 days)
- Incidence of major adverse cardiac and cerebral events(Within 30 days after surgery)
- Activities of daily living（ADL）(Within 30 days after surgery)
- Length of ICU stay(From the date of admission until discharged from ICU, up to 30 days)
- EEG characteristics(Within 30 days after surgery)
研究者
Anshi Wu
Director of department of anesthesiology, Chaoyang Hospital
Beijing Chao Yang Hospital