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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04247997
Enrollment
116
Registered
2020-01-30
Start date
2020-02-01
Completion date
2023-02-01
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Chronic Cough

Keywords

postoperative chronic cough, pulmonary vagus nerve branch, autonomic nervous system, pulmonary nerves, thoracoscopic lobectomy

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.

Interventions

PROCEDUREdisconnect 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.

Sponsors

Han Yuan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of chronic cough after surgery3 months after surgeryMore 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.

Secondary

MeasureTime frameDescription
The score of the LCQ-MC scale after surgery1 month and 3 months after surgeryThe LCQ-MC was designed for the assessment of a chronic cough, consists of 19 items and three domains.
Length of operationduring the operation
volume of bleedingduring the operation
volume of postoperative drainagewithin 30 days after surgery
the frequence of perioperative arrhythmiaduring the operation
The incidence of chronic cough after surgery1 month after surgeryMore 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.
the score of Cough symptompostoperative 1 day,2 days,3 days,4 days,5 days,6 daysThe 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.
the time of extubationwithin 30 days after surgery
the incidence of gastrointestinal symptomswithin 3 months after surgerygastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea
the incidence of postoperative hospitalizationwithin 30 days after surgery
pulmonary function 30 months after surgery30 months after surgerymaximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume
the incidence of Postoperative complicationwithin 30 days after surgerypulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026