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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Medical University Union Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tubeless anesthesia

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: Control group (traditional tracheal intubation group)Other 1 intervention
Group B: Experimental group (Tubeless anesthesia group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 days after surgery

Secondary outcomes

1

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.

Time frame
During surgery
2

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.

Time frame
The beginning and once at the end of the surgery.
3

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.

Time frame
During surgery
4

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.

Time frame
After surgery

Other outcomes

Sponsors and contacts

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