A Randomized Single-blind Clinical Trial of the Efficacy and Safety of Remimazolam in Painless Bronchoscopy
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Over the past decade, bronchoscopy technology has developed rapidly and has become an
important part of the diagnosis and treatment of respiratory diseases. Bronchoscopy are
usually carried out under monitored anesthesia care (MAC), which can relieve the anxiety of
the patient, make the operation easier, and improve the completion rate of bronchoscopy. At
present, bronchoscopy has widely used midazolam, propofol, short-acting opioids, and newer
sedatives such as dexmedetomidine, but each drug has its limitations. Dexmedetomidine is
widely used in non-intubation general anesthesia and sedation during short outpatient
surgery. However, rapid and high-dose infusion of dexmedetomidine leads to dose-dependent
hypotension, temporary hypertension, bradycardia, and excessive sedation, causing hemodynamic
fluctuations. At the same time, it has slow onset and metabolism. This may be a potential
risk for some elderly patients with many underlying diseases and unstable hemodynamics.
Remimazolam is an ultra-short-acting benzodiazepine. It has the advantages of short action
time, low accumulation, low risk of respiratory depression, and reversibility. We believe
that remimazolam can improve the onset time and resuscitation time, to achieve sufficient
sedation, improve the success rate of bronchoscopy, while reducing the patient's oxygen
saturation drop during the operation, postoperative opioid-related nausea and vomiting,
postoperative delirium and other related adverse events. This study is a randomized
controlled trial to confirm the above hypothesis.
Phase:
Phase 4
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University