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

NCT ID: NCT07024433

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-25
• Study Completion Date: 2027-12-03

Brief 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.

Detailed Description

With changes in lifestyle and environment, the incidence of early-stage lung cancer has been increasing annually. Traditional open surgical treatments have drawbacks such as significant trauma and noticeable pain, which has led to increased interest in minimally invasive surgery. In recent years, with continuous advancements in technology, single-port thoracoscopic surgery has become a popular choice for minimally invasive procedures, offering advantages such as minimal intraoperative trauma, mild postoperative pain, and good cosmetic results. However, traditional tracheal intubation and mechanical ventilation carry a range of potential side effects, including pressure-induced injury, lung overdistension, and the release of various pro-inflammatory mediators. Additionally, ventilator-associated lung injury occurs in about 4% of patients undergoing lung resection, with a mortality rate reaching up to 25%. The possibility of subclinical lung injury may also be underestimated. Furthermore, orotracheal and bronchial intubation can lead to various local complications, including upper respiratory tract pain, mucosal ulcers, and injury to the larynx or trachea. General anesthesia might have harmful systemic side effects, whereas local anesthesia does not pose such issues for awake patients or those with minimal sedation. Moreover, the use of muscle relaxants can lead to diaphragmatic dysfunction and atelectasis. Intravenous analgesics, especially opioids, are associated with postoperative vomiting, nausea, and respiratory depression. Importantly, postoperative pulmonary complications are among the most common complications following such surgeries, including atelectasis, lung infections, and pleural effusions, which can severely affect patient recovery and even be life-threatening. Therefore, it is crucial to find an anesthesia technique that ensures surgical efficacy while reducing postoperative pulmonary complications.

Tubeless anesthesia, which implies retaining spontaneous breathing without tracheal intubation, refers to a general anesthesia technique that does not involve tracheal intubation during thoracoscopic surgery. It employs airway devices that do not invade the trachea, alongside regional anesthesia and intravenous sedation and analgesics, to preserve spontaneous breathing. As a new anesthetic technique emerging in recent years, it offers several advantages over traditional methods, such as faster recovery, alignment with the needs of minimally invasive surgery, and a reduction in postoperative complications. Currently, the reported application range of tubeless anesthesia is extensive, encompassing simple lung biopsies, bullectomies, treatments for hyperhidrosis, as well as wedge resections, lobectomies, segmentectomies, and mediastinal tumor surgeries, even including complex tracheal tumor resections and carina reconstructions. The surgical approaches include multipoint and single-port procedures, as well as Da Vinci robotic surgeries. Although retrospective studies have confirmed the feasibility, safety, and efficacy of tubeless anesthesia in thoracoscopic-assisted minimally invasive surgery, the focus has predominantly been on the occurrence of ipsilateral lung complications.

Currently, reports on the preventive value and safety of this technique for contralateral lung complications in single-port thoracoscopic surgery in early-stage lung cancer patients are scarce, and prospective research evidence is lacking. Therefore, the primary aim of this study is to apply tubeless anesthesia in single-port thoracoscopic surgery for early-stage lung cancer patients, and to compare the incidence of contralateral lung complications three days postoperatively, perioperative hemodynamics, perioperative complication rates, and recovery speed with patients having similar baseline conditions who underwent traditional single-lumen tube + blocking tube or double-lumen tracheal intubation general anesthesia, to verify its clinical value.

Conditions

Lung Cancer Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group (traditional tracheal intubation group)

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.

Group Type: OTHER

Traditional tracheal intubation

Intervention Type: PROCEDURE

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.

Experimental group (Tubeless anesthesia group)

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.

Group Type: EXPERIMENTAL

Tubeless anesthesia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shishi Huang

Role: CONTACT

twolions1997@163.com

+81 18120825212

Facility Contacts

Xiaodong Xu

Role: primary

chenandi1997@163.com

+86-18359185681

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Other Identifiers

2024YF068-01

Identifier Type: -

Identifier Source: org_study_id