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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
propofol and alfentanil
DrugGeneral anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.
remimazolam combined with propofol and alfentanil
DrugGeneral anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of hypoxia(75% ≤ SpO2 < 90% for <60 s)
Secondary outcomes
The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
Non-Invasive Blood Pressure changes: The area under the curve (AUC) of the patient's mean blood pressure over time from pre-anesthesia induction to the end of bronchoscopy during patient monitoring
The area under the curve (AUC) of the patient's mean blood pressure during observation in Post-Anesthesia Care Unit
The dosage of vasoactive drugs administered.
Other outcomes
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Sponsors and contacts
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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