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Recruiting NCT07395596

Remimazolam for Bronchoscopy in High-Risk Patients

Phase IV Interventional Pulmonary Infection Pulmonary Nodule Phthisis Endotracheal Tumour

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: propofol and alfentanil, remimazolam combined with propofol and alfentanil.
Who it may be relevant to
Registry conditions: Pulmonary Infection, Pulmonary Nodule, Phthisis, Endotracheal Tumour. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Primary outcome measures

  • The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s） [Time frame: Periprocedural]
Secondary outcome measures (4)
  • The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s） [Time frame: Periprocedural]
  • Non-Invasive Blood Pressure changes: The area under the curve (AUC) of the patient's mean blood pressure over time from pre-anesthesia induction to the end of bronchoscopy during patient monitoring [Time frame: Periprocedural]
  • The area under the curve (AUC) of the patient's mean blood pressure during observation in Post-Anesthesia Care Unit [Time frame: Periprocedural]
  • The dosage of vasoactive drugs administered. [Time frame: Periprocedural]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 2 centers
  • The First Affliated Hospital, Zhejiang University School Of Medicine — Hangzhou
  • Shaoxing City First People's Hospital — Shaoxing

Identifiers

NCT: NCT07395596 · ZJU2026B0127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗