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NCT Number: NCT07395596

Remimazolam for Bronchoscopy in High-Risk Patients

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.

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Key information

Conditions

Pulmonary Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Endotracheal Tumour Gram-Positive Bacterial Infections Hypoxia Infections Lung Diseases Lymphadenectasis Mycobacterium Infections Pathological Conditions, Signs and Symptoms Phthisis Pulmonary Nodule Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Tuberculosis Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affliated Hospital, Zhejiang University School Of Medicine, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol and Alfentanil

Drug

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

remimazolam combined with propofol and alfentanil

Drug

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

Primary outcomes

  1. The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）

    Time frame: Periprocedural

Secondary outcomes

  1. The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）

    Time frame: Periprocedural

  2. 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

  3. The area under the curve (AUC) of the patient's mean blood pressure during observation in Post-Anesthesia Care Unit

    Time frame: Periprocedural

  4. The dosage of vasoactive drugs administered.

    Time frame: Periprocedural

Other outcomes

  1. The incidence of other adverse events

    Time frame: Periprocedural

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Study contacts

Contact information is provided by the study sponsor or research team.

Yeke Zhu

CONTACT

[email protected]

+8613515815457

Yueying Zheng

CONTACT

[email protected]

+8613777408863

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Affiliated Hospital of Jiaxing University
  • Shaoxing People's Hospital
  • The Second Affiliated Hospital of Jiaxing University

Registry information

Official study title

A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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