Actively Recruiting
Opioid-Free Combined Anesthesia with Preserved Spontaneous Breathing for Video-Assisted Thoracoscopic Surgery of Pulmonary Nodules A Multicenter Randomized Controlled Clinical Study
Led by Tongji Hospital · Updated on 2025-01-03
480
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of opioid-free combined anesthesia with preserved spontaneous breathing during video-assisted thoracoscopic surgery (VATS) for lung nodules. This study aims to assess how this "opioid-sparing strategy," which replaces opioids with ketamine during surgery, impacts recovery quality and speed, lung function, pain, gastrointestinal function, nausea, cognitive function, and mental health after surgery. The research is designed as a prospective, multicenter, randomized controlled trial with a 2x2 factorial design to provide high-level clinical evidence on these anesthesia approaches. The trial compares two ventilation methods—preserved spontaneous breathing using a laryngeal mask airway and mechanical ventilation via a double-lumen tracheal tube—along with two anesthesia approaches: opioid-based combined anesthesia and opioid-free combined anesthesia using esketamine. This creates four patient groups receiving different combinations of ventilation and anesthesia during their VATS lung nodule surgery. Experienced anesthetists and thoracic surgeons at six hospitals in China will conduct the study. Participants will be observed across three phases: the perioperative phase (day 0 to 2), the postoperative hospital stay (day 3 to 7), and a short-term follow-up period (day 8 to 30). Researchers will monitor lung function and adverse events related to anesthesia throughout these phases. The primary outcome is lung function measured 30 days after surgery. The study also tracks pain, pulmonary complications, gastrointestinal symptoms, nausea and vomiting, cognitive function, and emotional well-being to evaluate overall recovery and safety.
CONDITIONS
Official Title
Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA grades 1-2
- Age greater than 18 years and less than 70 years
- Male or female patients
- Planned video-assisted thoracoscopic surgery (VATS) for lung nodule under general anesthesia
- Voluntarily agree to participate and provide informed consent
You will not qualify if you...
- Surgery aborted
- Serious adverse events, complications, or special physiological changes during perioperative period that prevent continuation
- Expanded surgical scope including complex lung segment or lobectomy, enlarged incision thoracoscopic surgery, pulmonary blood vessel or airway reconstruction, partial pericardiectomy, or conversion to thoracotomy
- Need for a second operation within one month
- Patient or guardian requests withdrawal
- Other reasons deemed by researchers to discontinue the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
H
Hui Xu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here