pulmonary tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 60 inclusive; 2. No gender restrictions; 3. Patients with pulmonary tuberculosis or non-tuberculous lung disease undergoing routine bronchoscopy; 4. ASA classification =II; 5. Body mass index (BMI) between 18.5 kg/m² and 23.9 kg/m²; 6. Informed consent obtained, with voluntary participation in this trial and the patient personally signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Complex or highly invasive bronchoscopic diagnostic or therapeutic procedures are required; 2. The anticipated procedure duration exceeds 20 minutes; 3. The patient experiences severe communication difficulties due to factors such as profound hearing impairment; 4. Additional medications beyond the preoperative preparation regimen, sedation protocol, and saline solution are anticipated during the procedure for various reasons (e.g., topical application of noradrenaline for haemostasis; intraoperative occurrence of rapid ventricular rate atrial fibrillation requiring pharmacological management, etc.); 5. Pregnant or lactating females; 6. Subjects with a history of severe motion sickness or vertigo; 7. Subjects presenting difficult airway conditions such as Mallampati classification = Grade III, limited neck mobility, or short mentoglenoid distance (40% ABV/150ml wine); 9. Explicit refusal to participate in this study; 10. Participation in other drug or device clinical trials within three months prior to the screening period; 11. Failure to adhere to standard protocols for washout of prohibited medications or continued use of prohibited drugs; 12. Inability to confirm whether prohibited drugs were taken within the preceding seven days; 13. Patients deemed unsuitable for this study by the investigator; 14. Electrocardiogram (ECG) demonstrating significant abnormalities including severe bradycardia, complete left anterior fascicular block, incomplete left anterior fascicular block with bradycardia, Wolff-Parkinson-White syndrome, rapid atrial fibrillation, or frequent ventricular premature beats; 15. Patients infected with HIV; 16. Patients who have used antibiotics or anti-tuberculosis drugs within three months prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major postoperative discomfort symptoms;Other postoperative discomfort symptoms;Postoperative sleep status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sedation success rate;Sedation induction time;Additional times of propofol;Adverse events such as hypotension, hypoxemia, arrhythmia, etc.;Sedation recovery time;Subjects, drug users, endoscopists; | — |
Countries
China
Contacts
the Second Hospital of Nanjing