Clinical trial NCT04247997: Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy
Official title: Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Chronic Cough
Keywords: postoperative chronic cough
pulmonary vagus nerve branch
autonomic nervous system
pulmonary nerves
thoracoscopic lobectomy
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* ASAⅠ-Ⅲ

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The incidence of chronic cough after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
measure: The incidence of chronic cough after surgery
timeFrame: 1 month after surgery
measure: The score of the LCQ-MC scale after surgery
timeFrame: 1 month and 3 months after surgery
measure: Length of operation
timeFrame: during the operation
measure: volume of bleeding
timeFrame: during the operation
measure: volume of postoperative drainage
timeFrame: within 30 days after surgery
measure: the frequence of perioperative arrhythmia
timeFrame: during the operation
measure: the incidence of Postoperative complication
timeFrame: within 30 days after surgery
measure: the score of Cough symptom
timeFrame: postoperative 1 day,2 days,3 days,4 days,5 days,6 days
measure: the time of extubation
timeFrame: within 30 days after surgery
measure: the incidence of gastrointestinal symptoms
timeFrame: within 3 months after surgery
measure: the incidence of postoperative hospitalization
timeFrame: within 30 days after surgery
measure: pulmonary function 30 months after surgery
timeFrame: 30 months after surgery
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References: