Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery: a Double-blinded Randomized Placebo Controlled Trials
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- incidence of POAF
研究概览
简要总结
This study intends to explore a new therapy to reduce the incidence of atrial fibrillation in thoracic patient who receive video-assisted thoracoscopic lobectomy .The results of the study are to assess the effects of this new intervention on the incidence，duration of atrial fibrillation and other complications including postoperative delirium after video-assisted thoracoscopic lobectomy .And reducing the burden of POAF on patients and their families, hospitals and public resources.
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
Intervention is not blinded to anesthesiologists and nurses participating intraoperative management.These anesthesiologists and nurses will not participate the follow-up study of this patient.Surgeons performing surgery are blinded.
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
- •Thoracoscopic lobectomy and bilobectomy
- •ASA class I-III
- •Age is greater than or equal to 50 years old
- •Han Nationality, mother tongue is chinese
- •The people signed informed consent
排除标准
- •history of chronic atrial arrhythmia
- •sick sinus syndrome
- •history of second-degree atrioventricular block
- •taking class I or class III antiarrhythmic drugs or β-receptor blocker
- •history of radiofrequency ablation
- •hyperthyroidism
- •contraindications of ropivacaine, lidocaine
- •pregnancy and lactation
结局指标
主要结局
incidence of POAF
时间窗: 72 hours after surgery
Continuous ECG recordings were made on Holter recorders for 72 hours after the operation. Arrhythmia detection were done automatically by template matching. The decisions made automatically by the computer were reviewed and corrected by an experienced technician and then by a cardiologist.
次要结局
- the Trail Making Test(3-6months after surgery)
- the Grooved Pegboard Test(3-6months after surgery)
- the Digit Span Test(3-6months after surgery)
- the Number-Symbol Replacement Test(3-6months after surgery)
- the Finger Tapping Test(3-6months after surgery)
- the Word Fluency Test(3-6months after surgery)
- the Building Block Test(3-6months after surgery)
- Mini-Mental score examination (MMSE)(1 day before surgery(baseline)，6±1 days after surgery，one month after surgery)
- Quality of Recovery Score - 40 (QoR-40)(1 day before surgery(baseline)，1 day after surgery)
- specific time of POAF(72 hours after surgery)
- incidence of other arrhythmia(15-30 days after surgery)
- Ventricular rate during POAF(72 hours after surgery)
- Incidence of postoperative delirium(before discharge from PACU，twice a day every 12 hours within 3 days after surgery)
- Numerical Rating Scale（NRS）(before discharge from PACU，twice a day every 12 hours within 3 days after surgery)
- incidence of POAF(15-30 days after surgery)
- incidence of postoperative complications(1-30 days after surgery)
- re-admission within 30 days after surgery(1-30 days after surgery)
- mortality(within 30 days after surgery)
- hospitalization expenses(up to 30 days after surgery)
- Postoperative length of stay(up to 30 days after surgery)
- admission into ICU(up to 30 days after surgery)
- Analgesic dose(up to 7 days after surgery)
- incidence of second operation(1 month after surgery)
研究者
Han Yuan
Doctor-in-charge of Anesthetist
Xuzhou Medical University