Tubeless Anesthesia in Preventing Lung Complications in Patients Undergoing Surgery for Early-Stage Lung Cancer

NCT07024433 · tracked via the Priya Life Science China tracker

Sponsor

Fujian Medical University Union Hospital

Phase

Not applicable

Started

2025-05-25

Last updated

2025-06-17

Condition(s) studied

Lung Cancer Patients

Investigational drug(s) / intervention(s)

Tubeless anesthesiaTraditional tracheal intubation

Tubeless anesthesia: 1. Anesthesia Induction: Implement TCI with propofol and remifentanil; insert a laryngeal mask for SIMV ventilation, and monitor vital signs including IBP and end-tidal CO2. 2. Nerve Blocks: Perform ultrasound-guided paravertebral, pleural surface, and vagus nerve blocks using local anesthetics. 3. Anesthesia Maintenance: Adjust remifentanil for spontaneous breathing; maintain propofol and BIS levels; manage heart rate and blood pressure with fluids and medication as needed, without using inhaled anesthetics. 4. Postoperative Analgesia: Provide PCIA with morphine for pain management.

Traditional tracheal intubation: 1. Anesthesia induction using propofol, sufentanil, and rocuronium is performed, with DLT or single-lumen tube insertion at BIS≤60 for single-lung ventilation, maintaining appropriate oxygen and ventilation parameters. 2. Anesthesia is maintained with sevoflurane, propofol, and remifentanil, supplementing rocuronium every 30-40 minutes for muscle relaxation, with BIS maintained at 40-60. 3. Post-surgery, ultrasound-guided thoracic paravertebral block and PCIA are used for analgesia, with extubation following standard recovery procedures.

Study summary

The study focuses on evaluating the effectiveness and safety of tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients. Traditional anesthesia methods risk postoperative complications like lung injury and respiratory issues. Tubeless anesthesia preserves spontaneous breathing without tracheal intubation, potentially reducing these complications and enhancing recovery. The study aims to compare this technique with traditional methods, assessing its impact on contralateral lung complications, perioperative hemodynamics, complication rates, and recovery speed.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Age ≥18 years and ≤70 years; 2. ECOG performance status score 0-1; 3. Good cardiac and pulmonary function; 4. Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling; 5. Able to comply with the study visit schedule and other protocol requirements; 6. Signed informed consent and voluntary participation in the study. Exclusion Criteria: 1. Obese patients (BMI \>30); 2. Patients with difficult intubation or expected complex airway management; 3. COPD patients with copious airway secretions; 4. Patients with neurological dysfunction or who cannot cooperate while awake; 5. Patients expected to have extensive pleural adhesions or with previous lung resection; 6. Elderly and frail patients with severe hypoxia (PaO2 \<60 mmHg) or hypercapnia (PaCO2 \>50/55 mmHg); 7. Previous induction chemotherapy or chemoradiotherapy; 8. Intraoperative need to isolate the lung to prevent spillage and contamination of the contralateral lung; 9. Patients expected to have large surgical wounds and lengthy procedures, clinically assessed as unsuitable; 10. Patients whose cardiac and pulmonary function, or overall health, cannot withstand the procedure.

Primary outcome measure(s)

Contralateral lung complications — 3 days after surgery
This measure will determine the number of patients experiencing complications in the contralateral lung, as diagnosed through chest X-rays, within three days following surgery.

Trial sites (1)

Facility	City	Region	Status
Fujian Medical University Union Hospital	Fuzhou	Fujian	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07024433 on ClinicalTrials.gov ↗ ← All trials in China