NCT07395596

Remimazolam for Bronchoscopy in High-Risk Patients

A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bronchoscopy is currently widely used for the diagnosis and treatment of various respiratory diseases. However, the operation of bronchoscopy is irritating, causes a strong stress response, and shares the airway with the patient, making the patient highly susceptible to respiratory and cardiovascular risks. Among these risks, hypoxia is the most common adverse event.Different drug regimens can be selected for anesthesia under deep sedation. The combination of analgesic agents can help reduce coughing during bronchoscopy. Therefore, we employ a combination of sedative and analgesic drugs for painless bronchoscopy procedures. Among sedatives, propofol is the most commonly used. However, due to its disadvantages, such as respiratory and circulatory depression, we have introduced a novel approach combining remimazolam for sedation. The aim is to investigate whether this new regimen, compared to traditional propofol-based sedation, can reduce the incidence of hypoxia, minimize circulatory depression, and lead to faster postoperative awakening and recovery. Additionally, we hope to observe fewer adverse events, such as perioperative nausea and vomiting, excessive secretions, dizziness, and chills.

Conditions

• Pulmonary Infection
• Pulmonary Nodule
• Phthisis
• Endotracheal Tumour
• Lymphadenectasis

Interventions

Type	Name	Description
DRUG	propofol and alfentanil	General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.
DRUG	remimazolam combined with propofol and alfentanil	General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.

Timeline

• Start date: 2026-02-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-09
• Last updated: 2026-02-24

Locations

2 sites across 1 country: China