Remimazolam for Bronchoscopy in High-Risk Patients

NCT07395596 | Recruiting Phase 4

• 1 other identifier: ZJU2026B0127
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

hypoxia; remimazolam; propofol; fiberoptic bronchoscopy

Outcome Measures

Primary Outcomes (1)

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

  Periprocedural

Secondary Outcomes (4)

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

  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

  Periprocedural

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

  Periprocedural

• The dosage of vasoactive drugs administered.

  Periprocedural

Other Outcomes (1)

• The incidence of other adverse events

  Periprocedural

Study Arms (2)

The propofol - alfentanil group（The control group）

ACTIVE COMPARATOR

In this group, general anesthesia was administered using the classic propofol and alfentanil. The patients underwent fiberoptic bronchoscopy while maintaining spontaneous breathing and with a MOAA/S score of ≤2.

Drug: propofol and alfentanil

The remimazolam and propofol - alfentanil group (The experimental group)

EXPERIMENTAL

This group received general anesthesia with remimazolam combined with propofol for sedation and alfentanil. Fiberoptic bronchoscopy was done while patients maintained spontaneous breathing and had a MOAA/S score of ≤2.

Drug: remimazolam combined with propofol and alfentanil

Interventions

propofol and alfentanil DRUG

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

The propofol - alfentanil group（The control group）

remimazolam combined with propofol and alfentanil DRUG

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

The remimazolam and propofol - alfentanil group (The experimental group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Affiliated Hospital of Jiaxing University: collaborator
• Shaoxing People's Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator

Study Sites (2)

The First Affliated Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Shaoxing City First People's Hospital

Shaoxing, Zhejiang, 310000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Hypoxia

Interventions

Propofol; Alfentanil

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yueying Zheng

CONTACT

+8613777408863; 1507128@zju.edu.cn

Yeke Zhu

CONTACT

+8613515815457; 21618018@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of the Department of Anesthesiology

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: February 9, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (2)