Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stability During Surgical Operation
- Sponsor
- Guangzhou Institute of Respiratory Disease
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- numbers of participants with postoperative respiratory and cardiovascular complications
- Last Updated
- 7 years ago
Overview
Brief Summary
With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely applied in VATS. A multicenter randomized parallel controlled study was applied in this study to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.
Detailed Description
Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the standard of care in VATS. However, this type of anesthesia has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.
Investigators
Jun Liu
Professor
Guangzhou Institute of Respiratory Disease
Eligibility Criteria
Inclusion Criteria
- •volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
- •16-50 years old
- •preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment
- •Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1
- •ASA（American Society of Anesthesiologists score） ≤ 2
- •Heart ejection fraction( EF)≥ 50%
Exclusion Criteria
- •refusing to participate in clinical trials
- •A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion
- •BMI ≥ 25 kg/m\^2
- •other not suitable situations
Outcomes
Primary Outcomes
numbers of participants with postoperative respiratory and cardiovascular complications
Time Frame: from operation to discharging, an average of 1 week
The numbers of participants with postoperative respiratory and cardiovascular complications will be reported. The postoperative complications include postoperative respiratory complications(e.g., air leaks, lung infections, atelectasis, and bronchospasm and respiratory failure), postoperative cardiovascular complications(e.g., arrhythmias, myocardial infarction, cardiac failure) , intubated related complications(e.g., hoarseness, sore throat, and irritating cough), and other undefined complications
Secondary Outcomes
- numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively(during the surgical operation, an average of 1 hour)
- numbers of participants with anesthesia conversion intraoperatively in nonintubated group(during the surgical operation, an average of 1 hour)
- numbers of participants with postoperative complications(from operation to discharging, an average of 1 week)