A Prospective, Randomized Controlled Study Comparing Remimazolam and Propofol on Hypoxia Incidence in High-Risk Patients Undergoing Painless Bronchoscopy

What this Trial Is About

Researchers are evaluating a new sedation approach for patients undergoing painless bronchoscopy, a procedure commonly used to diagnose and treat respiratory diseases but known to cause stress and risks such as hypoxia. The study compares a traditional sedation method using propofol and alfentanil with a novel combination including remimazolam to see if it can reduce respiratory and cardiovascular complications and improve recovery times. Participants are randomly assigned to one of two groups. One group receives general anesthesia with propofol and alfentanil, while the other group receives remimazolam combined with propofol and alfentanil. Both groups maintain spontaneous breathing during fiberoptic bronchoscopy, aiming for a moderate level of sedation. The study observes patients throughout the procedure and recovery to assess the effects of these drug regimens. During the trial, researchers monitor the incidence of hypoxia and severe hypoxia as primary and secondary outcomes. They also track blood pressure changes, vasoactive drug use, and postoperative recovery. The trial includes triple blinding to ensure unbiased results. Participants are observed until recovery, with detailed monitoring of vital signs and adverse events such as nausea, vomiting, dizziness, and chills. The study is led by the First Affiliated Hospital of Zhejiang University and runs until December 2026.

Remimazolam for Bronchoscopy in High-Risk Patients