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NCT07395596RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 24 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
360 (estimated)
First submitted
7 Jul 2025
Start date
9 Feb 2026
Primary completion date
Dec 2026
Lead sponsor
First Affiliated Hospital of Zhejiang University
NCT number
NCT07395596

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 360
  • From 9 Feb 2026 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients who are uncooperative(e.g. due to mental illness)
  • Patients with a history of allergy to the anesthetics used

Age

  • Age \< 18 years

Other

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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affliated Hospital, Zhejiang University School Of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Shaoxing City First People's Hospital
Coordinator of this site? Confirm its status
ShaoxingChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.