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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a sedative called remimazolam works safely and effectively during bronchoscopy — a procedure where a doctor uses a thin, flexible camera to look inside the lungs — in patients who have serious underlying health conditions. **You may be eligible if...** - You are 18 or older - You have significant medical health problems (classified as ASA Class 3 or 4, meaning serious but stable or life-threatening conditions) - You are scheduled for a planned, non-emergency bronchoscopy procedure **You may NOT be eligible if...** - You are unable to cooperate, for example due to a mental health condition - You regularly use opioids, sleeping pills (benzodiazepines), or antidepressants - You have a known allergy to anesthesia medications - Your airway is expected to be difficult to manage - Your BMI is below 18.5 or above 30 - Your blood oxygen level is below 92% while breathing room air Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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