Remimazolam for Bronchoscopy in High-Risk Patients

Last updated: February 21, 2026
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Active - Recruiting

Phase

4

Condition

Bronchitis (Pediatric)

Treatment

propofol and alfentanil

remimazolam combined with propofol and alfentanil

Clinical Study ID

NCT07395596
ZJU2026B0127
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA Class Ⅲ - Ⅳ

  • Scheduled for elective painless bronchoscopy -

Exclusion

Exclusion Criteria:

  • Age < 18 years

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

  • Patients who are on chronic use of opioids, benzodiazepine - class hypnotics, orantidepressants

  • Patients with a history of allergy to the anesthetics used

  • Patients who are anticipated to have a difficult airway

  • Body mass index(BMI)<18.5kg/m² or >30kg/m²

  • Preoperative oxygen saturation <92% while breathing room air

  • Other:Patients who are deemed by the investigator to be unsuitable for participationin this trial

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: propofol and alfentanil
Phase: 4
Study Start date:
February 09, 2026
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • The First Affliated Hospital, Zhejiang University School Of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310000
    China

    Active - Recruiting

  • Shaoxing City First People's Hospital

    Shaoxing 1795855, Zhejiang 1784764 310000
    China

    Site Not Available

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