Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy

Postoperative Chronic Cough Clinical Trial

Official title:

Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247997
• Other study ID #: XYFY2019-KL179-01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 1, 2023
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• ASA?-?

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.

Related Conditions & MeSH terms

• Cough
• Postoperative Chronic Cough

Intervention

Procedure:
• disconnect pulmonary vague nerve branches
When the operation is in the right side, the Azygous vein bow is used as the marker, and in the left side, the aortic arch is used as the marker to identify the vagus nerve trunk.Then the surgeons dissect the vagus nerve trunk. This is used as a clue to find the vagus nerve pulmonary branch leading to the hilum. The position of the detachment is after the anterior and posterior pulmonary branches of the vagus nerve separating from the trunk and before the formation of the lung plexus.

Locations

Country	Name	City	State
China	Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Han Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of chronic cough 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.	3 months after surgery
Secondary	The incidence of chronic cough 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.	1 month after surgery
Secondary	The score of the LCQ-MC scale after surgery	The LCQ-MC was designed for the assessment of a chronic cough, consists of 19 items and three domains.	1 month and 3 months after surgery
Secondary	Length of operation		during the operation
Secondary	volume of bleeding		during the operation
Secondary	volume of postoperative drainage		within 30 days after surgery
Secondary	the frequence of perioperative arrhythmia		during the operation
Secondary	the incidence of Postoperative complication	pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident	within 30 days after surgery
Secondary	the score of Cough symptom	The score was used to record daily symptom score for cough severity.The scale is scored by 4 levels at day and night respectively.The higher score means worse symptom.	postoperative 1 day,2 days,3 days,4 days,5 days,6 days
Secondary	the time of extubation		within 30 days after surgery
Secondary	the incidence of gastrointestinal symptoms	gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea	within 3 months after surgery
Secondary	the incidence of postoperative hospitalization		within 30 days after surgery
Secondary	pulmonary function 30 months after surgery	maximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume	30 months after surgery