About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and ≤70 years;
ECOG performance status score 0-1;
Good cardiac and pulmonary function;
Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling;
Disqualifiers
Obese patients (BMI >30);
Patients with difficult intubation or expected complex airway management;
COPD patients with copious airway secretions;
Patients with neurological dysfunction or who cannot cooperate while awake;
Trial design
Parallel
Treatments tested in this trial
Tubeless anesthesia
Procedure/Surgery1. 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
Procedure/Surgery1. 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.
Treatment groups
Trial outcomes
Primary outcomes
Contralateral lung complications
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.
Secondary outcomes
Intraoperative hemodynamic analysis
Hemodynamic stability is monitored through three physiological parameters: heart rate (beats per minute), systolic blood pressure, and diastolic blood pressure (mmHg). During the surgery, these measurements are taken every 15 minutes, and the results for each parameter are reported in their respective units.
Intraoperative Blood Gas Analysis
This measurement includes arterial blood gas analysis, comprising pH value, partial pressure of oxygen (PaO2 \[mmHg\]), partial pressure of carbon dioxide (PaCO2 \[mmHg\]), and bicarbonate levels (HCO3- \[mmol/L\]). Measurements are taken once at the beginning and once at the end of the surgery.
Consumption of Anesthetics and Vasoactive Drugs
The total consumption of anesthetics (measured in mg) and vasoactive drugs (measured in micrograms per kilogram per minute \[mcg/kg/min\]) will be documented. The data will reflect the total dosage administered during the perioperative period.
Visual Analogue Scale (VAS) for Pain Assessment
Pain levels will be evaluated using the Visual Analogue Scale, which ranges from 0 (no pain) to 10 (worst possible pain). Data will be collected postoperatively and presented as an average score.
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