Remimazolam sedation for high-risk patients undergoing bronchoscopy
Official title: A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy
Run by First Affiliated Hospital of Zhejiang University · NCT07395596 · Data updated 2026-11-12
This test checks whether adding remimazolam to propofol and alfentanil lowers the chance of low oxygen (hypoxia) and circulatory problems during bronchoscopy in high-risk adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Status | Recruiting |
| Started | February 9, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07395596 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with ASA class III–IV scheduled for elective painless bronchoscopy who meet the trial's BMI and preoperative oxygenation criteria are the intended participants.
✕Probably not a fit
Patients under 18, those with BMI outside 18.5–30 kg/m², preoperative SpO2 <92% on room air, chronic opioid/benzodiazepine use, anticipated difficult airway, known allergy to the anesthetics, or otherwise judged unsuitable by investigators are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional comparison enrolls adults with ASA physical status III–IV who are scheduled for elective painless fiberoptic bronchoscopy. Participants will receive either a remimazolam-containing sedation regimen combined with propofol and alfentanil or the conventional propofol plus alfentanil regimen, with monitoring during and after the procedure. The trial focuses on respiratory and cardiovascular safety outcomes, primarily the incidence of hypoxia, and also records hemodynamic instability and procedural tolerance. People with major exclusions such as BMI <18.5 or >30, preoperative SpO2 <92% on room air, chronic opioid or benzodiazepine use, anticipated difficult airway, or anesthetic allergy are not eligible.
Why it matters
Potential benefit: If successful, this regimen could reduce hypoxia and lessen circulatory depression during bronchoscopy, improving safety for high‑risk patients.
How similar studies have gone: Remimazolam has shown promising safety and more stable hemodynamics than propofol in some endoscopic sedation studies, but data specifically in high‑risk bronchoscopy patients remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA Class Ⅲ - Ⅳ * Scheduled for elective painless bronchoscopy - 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, 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
Where it's running
-
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China Recruiting -
Shaoxing City First People's Hospital
Shaoxing, Zhejiang, China Not yet recruiting
Study contacts
- Study coordinator: Yueying Zheng
- Email: 1507128@zju.edu.cn
- Phone: +8613777408863
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.