NCT05413460招募中不适用
Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment
Zhihong LU1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2022年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- number of patients with major in-hospital postoperative complications
研究概览
简要总结
In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). The postoperative outcomes including NIHSS (National Institute of Health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.
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
- •patients scheduled for cranial endovascular treatment
排除标准
- •American Society of Anesthesiologists class Ⅲ or higher
- •Hunt-Hess class Ⅲ or higher
- •body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡
- •large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
- •posterior circulation infarction
- •recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
- •severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
- •injury or infection of the skin around the acupoint area
- •participate in other clinical researchers within 3 months
- •history of neurological or psychiatric diseases
- •patients with implanted electrophysiological device
- •use of sedative or analgesics before surgery
- •patients with difficulty in communication
结局指标
主要结局
number of patients with major in-hospital postoperative complications
时间窗: from end of surgery to discharge from hospital, in an average of 7 days
major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma
次要结局
- serum interleukin-6 level at the end of the surgery(at end of the surgery)
- mortality by 6 months after surgery(from end of surgery to 6 months after surgery, in a total of 6 months)
- Score of Mini-mental State Examination at 1 day after surgery(at 24h after the end of surgery)
- mortality by 30 days after surgery(from end of surgery to 30 days after surgery, in a total of 30 days)
- mortality by 3 months after surgery(from end of surgery to 3 months after surgery, in a total of 3 months)
- serum tumor necrosis factor-α level at the end of the surgery(at end of the surgery)
- episodes of hypotension during surgery(from start of surgery to end of surgery, in an average of 2 hours)
- Score of Mini-mental State Examination at 3 days after surgery(at 72h after the end of surgery)
- visual analog scale of pain at 1 day after surgery(at 24h after the end of surgery)
- number of patients with major postoperative complications by 3 months after surgery(from end of surgery to 3 months after surgery, in a total of 3 months)
- visual analog scale of pain at 3 days after surgery(at 72h after the end of surgery)
- Rankin's score at 3 days after surgery(at 72h after the end of surgery)
- number of patients with major postoperative complications by 6 months after surgery(from end of surgery to 6 months after surgery, in a total of 6 months)
- duration of postoperative in-hospital stay(from end of surgery to discharge from hospital, in an average of 7 days)
- Quality of recovery score at 3 days after surgery(at 72h after the end of surgery)
研究者
Zhihong LU
Professor
Air Force Military Medical University, China
研究点 (1)
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