RecruitingPhase 4NCT07395596

Remimazolam for Bronchoscopy in High-Risk Patients

A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

360 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • ASA Class Ⅲ - Ⅳ
  • Scheduled for elective painless bronchoscopy -

Exclusion Criteria8

  • 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
  • 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 participation in this trial

Interventions

DRUGpropofol and alfentanil

General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.

DRUGremimazolam combined with propofol and alfentanil

General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.


Locations(2)

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Shaoxing City First People's Hospital

Shaoxing, Zhejiang, China

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NCT07395596


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