Opioid-free anesthesia for lung surgery
Opioid-Free Combined Anesthesia Under Spontaneous Breathing for Video-Assisted Thoracoscopic Surgery of Pulmonary Nodules: A Multicenter, Open-Label, Randomized Controlled, 2x2 Factorial Design Clinical Study
NA · Tongji Hospital · NCT06367218
This study is testing if using an opioid-free anesthesia approach during lung surgery helps patients recover better and have fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06367218 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of opioid-free combined anesthesia with preserved spontaneous breathing during video-assisted thoracoscopic surgery (VATS) for lung nodules. It employs a multicenter, randomized controlled design with four patient groups receiving different anesthesia strategies. The aim is to assess postoperative recovery, lung function, and complications across various phases of care. The study is conducted by experienced anesthetists and thoracic surgeons in six hospitals in China.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with ASA grades 1-2 scheduled for VATS pulmonary nodule surgery.
Not a fit: Patients requiring complex surgical procedures or those with serious adverse events during the perioperative period may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery and fewer complications for patients undergoing lung surgery.
How similar studies have performed: While the opioid-sparing strategy is gaining attention, high-level clinical evidence supporting its benefits in this specific context is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA grades 1-2 2. Age \> 18 years and \< 70 years 3. Male or female patients 4. VATS pulmonary nodule operation is planned under general anesthesia 5. Voluntarily participate in the study and sign the informed consent Exclusion Criteria: 1. Subject's operation is aborted 2. Serious adverse events, complications or special physiological changes during the perioperative period should not be continued 3. Expansion of surgical scope: resection of complex lung segment or complex lung lobectomy, thoracoscopic assisted small-incision surgery with enlarged incision, requiring pulmonary blood Tracheoplasty or bronchoplasty, partial pericardiectomy or conversion to thoracotomy 4. Those who need a second operation within a month 5. The patient or his/her guardian requests to withdraw on his/her own 6. Reasons why other researchers think the study needs to be discontinued
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Hui Xu, Professor
- Email: huixu@tjh.tjmu.edu.cn
- Phone: (86)-13971001596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Video-assisted Thoracoscopic Lung Surgery；Anesthesia