Remimazolam for Bronchoscopy in High-Risk Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

ASA Class Ⅲ - Ⅳ

Scheduled for elective painless bronchoscopy -

Disqualifiers

Age < 18 years

Patients who are uncooperative(e.g. due to mental illness)

Patients who are on chronic use of opioids, benzodiazepine - class hypnotics, or antidepressants

Patients with a history of allergy to the anesthetics used

Trial design

Treatments tested in this trial

  • propofol and alfentanil
  • remimazolam combined with propofol and alfentanil

Treatment groups

360 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

Shaoxing People's Hospital

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

The Second Affiliated Hospital of Jiaxing University

Collaborator