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Clinical Trials in China / NCT07395596
Recruiting Phase 4

Remimazolam for Bronchoscopy in High-Risk Patients

NCT07395596 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Zhejiang University
Phase
Phase 4
Started
2026-02-09
Last updated
2026-02-24

Condition(s) studied

Pulmonary InfectionPulmonary NodulePhthisisEndotracheal TumourLymphadenectasis

Investigational drug(s) / intervention(s)

propofol and alfentanilremimazolam combined with propofol and alfentanil →

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
The First Affliated Hospital, Zhejiang University School Of Medicine Hangzhou Zhejiang Recruiting
Shaoxing City First People's Hospital Shaoxing Zhejiang Not Yet Recruiting

More First Affiliated Hospital of Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07395596 on ClinicalTrials.gov ↗ ← All trials in China