NCT07395375

Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection

A Multicenter, Randomized, Controlled Trial of Non-Intubated Spontaneous Breathing Anesthesia Versus Intubated Mechanical Ventilation Anesthesia in Thoracoscopic Sublobar Resection: A Stratified Analysis Study Focusing on Safety and Recovery Quality

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a large clinical study that compares two different types of anesthesia for patients undergoing a specific kind of minimally invasive lung surgery (thoracoscopic sublobar resection) to remove small, early-stage lung nodules. The study aims to find out if a newer anesthesia method, known as "non-intubated anesthesia" (where patients breathe on their own with the help of a laryngeal mask airway and nerve blocks for pain control), is as safe as the traditional "intubated anesthesia" (which uses a breathing tube and a machine to breathe for the patient). The main goals of the study are, in order: 1. Safety First: To confirm that the non-intubated method does not lead to more lung complications within 30 days after surgery compared to the traditional method. 2. Effectiveness: If it is proven safe, the study will then check if patients receiving the non-intubated anesthesia have a better quality of recovery in the first 24 hours after surgery (e.g., less pain, fewer side effects like a sore throat, and a faster return to normal activities). Approximately 1600 patients from multiple hospitals will be randomly assigned (like flipping a coin) to receive one of the two anesthesia methods. Neither the patients nor the surgeons will be told which group the patient is in when assessing the main outcomes after surgery, to ensure the results are fair and unbiased. The results of this study will provide high-quality evidence to help doctors and patients choose the best and most comfortable anesthesia option for this type of lung surgery.

Conditions

• Pulmonary Nodules
• Lung Neoplasms
• Thoracic Surgery

Interventions

Type	Name	Description
PROCEDURE	Non-intubated Anesthesia	A novel anesthetic technique for thoracic surgery that avoids endotracheal intubation and mechanical ventilation. It typically involves intravenous sedation, the use of a laryngeal mask airway (LMA) for oxygenation, and regional nerve blocks (e.g., paravertebral block) for pain control. The key feature is the preservation of the patient's spontaneous breathing throughout the surgical procedure.
PROCEDURE	Conventional Intubated General Anesthesia	The current standard anesthetic technique for thoracoscopic surgery. It involves general anesthesia induced by intravenous agents, followed by the insertion of a double-lumen endotracheal tube to achieve one-lung ventilation. Anesthesia is maintained with inhalational or intravenous agents, and the patient's ventilation is fully controlled by a mechanical ventilator throughout the operation.
DEVICE	Laryngeal Mask Airway (LMA)	Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.
DRUG	Intravenous Sedation/Anesthesia (Spontaneous Ventilation)	Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.
DRUG	Regional Nerve Block (Paravertebral/Intercostal Block)	Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.
DEVICE	Double-lumen Endotracheal Tube (DLT)	Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.
DRUG	General Anesthesia With Neuromuscular Blockade	General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China