Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06367218

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China

Actively Recruiting

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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

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