Remimazolam sedation for high-risk patients undergoing bronchoscopy
A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy
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 |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Trial ID | NCT07395596 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.