Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- The incidence of chronic cough after surgery
研究概览
简要总结
The purpose of this study was to determine whether disconnecting pulmonary vagus nerve branch can abatement chronic cough in patients undergoing unilateral thoracoscopic lobectomy,compared with preserving pulmonary vagus nerve branch.
详细描述
After screening for the Inclusion criteria and the exclusion criteria, 116 patients undergoing unilateral thoracoscopic lobectomy are randomly assigned to two groups, disconnecting pulmonary vague nerve branches and preserving pulmonary vague nerve branches. The incidence of chronic cough after surgery is compared between groups.
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)
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
- •Patients with preoperative imaging of bronchial lung cancer below the secondary bronchus ,the maximum diameter of the tumor ≤ 5cm (T ≤ 2) and staging check not suggesting distant and mediastinal lymph node metastasis (N ≤ 1, M = 0) schedule to receive elective unilateral thoracoscopic lobectomy from 2019 to 2021 will be included in the trial.
排除标准
- •Chronic cough (>8 weeks), its causes including chronic bronchitis, asthma, gastroesophageal reflux disease, history of postnasal drip syndrome, and the use of ACEI drugs and so on;
- •other history of lung surgery;
- •patients with severe arrhythmia;
- •there are contraindications for anesthesia and surgery;
- •pregnancy and lactation.
研究组 & 干预措施
Group P
preserve the pulmonary vague nerve branches
Group D
disconnect pulmonary vague nerve branches
干预措施: disconnect pulmonary vague nerve branches (Procedure)
结局指标
主要结局
The incidence of chronic cough after surgery
时间窗: 3 months after surgery
More than 8 weeks after surgery, there is no clear cause of cough with stable chest CT excluding the diagnosis of postnasal drip syndrome, asthma or the use of Angiotensin-converting enzyme inhibitor(ACEI), etc.
次要结局
- the incidence of Postoperative complication(within 30 days after surgery)
- pulmonary function 30 months after surgery(30 months after surgery)
- The incidence of chronic cough after surgery(1 month after surgery)
- the frequence of perioperative arrhythmia(during the operation)
- the incidence of gastrointestinal symptoms(within 3 months after surgery)
- The score of the LCQ-MC scale after surgery(1 month and 3 months after surgery)
- Length of operation(during the operation)
- volume of bleeding(during the operation)
- volume of postoperative drainage(within 30 days after surgery)
- the score of Cough symptom(postoperative 1 day,2 days,3 days,4 days,5 days,6 days)
- the time of extubation(within 30 days after surgery)
- the incidence of postoperative hospitalization(within 30 days after surgery)
研究者
Han Yuan
Doctor-in-charge of Anesthetist
Xuzhou Medical University