NCT07524712: ENERGY-COUGH

Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough

Not yet recruiting NA Last updated 13 April 2026

What this trial tests

NA trial testing Energy Device Vagus Nerve Transection in Postoperative Cough in 248 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
1 April 2028

1 April 2028

Quick facts

Lead sponsor	Tongji Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	248
Start date	1 April 2026
Primary completion	1 April 2028
Estimated completion	1 April 2028
Sites	1 location across China

Drugs / interventions tested

• Energy Device Vagus Nerve Transection
• Mechanical Vagus Nerve Transection

Conditions studied

• Postoperative Cough — all drugs for Postoperative Cough →
• Cough Hypersensitivity Syndrome — all drugs for Cough Hypersensitivity Syndrome →

Sponsor

Tongji Hospital

Who can join

18 and older, any sex, with Postoperative Cough or Cough Hypersensitivity Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). However, there are significant disagreements in the thoracic surgery community regarding the strategy for managing the vagus pulmonary plexus, primarily because key clinical issues remain unresolved: How do surgical procedures affect the occurrence and development of CH? And how can these procedures be improved?

A large number of published studies have only analyzed "where to cut" while neglecting the surgical issue of "how to cut". Even with a high level of evidence, the conclusions remain contradictory. This is because doctors' preferences and changes in supply conditions can influence the selection of instruments. Differences in the energy of the instruments can lead to varying degrees and scopes of vagus nerve degeneration and collateral damage to the sympathetic pulmonary plexus, while CH is regulated by both the sympathetic and parasympathetic nervous systems.

This project intends to explore the correlation between the selection of surgical instruments and the occurrence and development of postoperative CH at the clinical level, providing a reference for optimizing surgical methods and preventing and treating postoperative CH after lung surgery.

The specific research objectives are: to clarify the correlation through a randomized controlled trial, comparing the patterns and changes in the occurrence and development of postoperative CH between two groups of patients whose autonomic nerve pulmonary plexus was transected using energy-based instruments versus mechanical methods.

Optimize the surgical procedure: Based on the above results, propose a safe, effective, and feasible surgical method to reduce intraoperative damage, prevent postoperative CH, and improve patients' quality of life.

Key problems to be solved: How do surgical operations affect the occurrence and development of CH? How can improvements be made?

1. Clinical issues:

① Do energy-based instruments (causing thermal damage, etc.) and mechanical transection (causing physical damage), which lead to varying degrees of vagus nerve injury and collateral sympathetic nerve damage, affect the occurrence and development of postoperative cough hypersensitivity (CH)?

② How to optimize surgical operations to reduce the incidence of postoperative CH and improve patients' quality of life?
2. Correlation mechanisms: How do different instruments and energy modes affect the pathophysiology of nerve injury, degeneration, and repair, and what are the correlation patterns and mechanisms between these and the occurrence and development of CH?

Publications & conference data

No peer-reviewed publications indexed yet for this trial.