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Remimazolam for Bronchoscopy in High-Risk Patients

NCT07395596 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-02-24

No results posted yet for this 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.

Conditions

  • Pulmonary Infection
  • Pulmonary Nodule
  • Phthisis
  • Endotracheal Tumour
  • Lymphadenectasis

Interventions

DRUG

propofol and alfentanil

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

DRUG

remimazolam combined with propofol and alfentanil

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

Sponsors & Collaborators

  • Shaoxing People's Hospital

    collaborator OTHER

  • Affiliated Hospital of Jiaxing University

    collaborator OTHER

  • The Second Affiliated Hospital of Jiaxing University

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395596 on ClinicalTrials.gov