Remimazolam for Bronchoscopy in High-Risk Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodule; Pulmonary Infection; Endotracheal Tumour; Phthisis; Lymphadenectasis
• Intervention / Treatment: Drug: propofol and alfentanil; Drug: remimazolam combined with propofol and alfentanil

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yeke Zhu; Phone Number: +8613515815457; Email: 21618018@zju.edu.cn
• Study Contact Backup: Name: Yueying Zheng; Phone Number: +8613777408863; Email: 1507128@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • the First Affliated Hospital, Zhejiang University School of Medicine
      • Contact: Phone Number: +8613515815457; Email: 21618018@zju.edu.cn
    • Shaoxing, Zhejiang, China, 310000
      • Not yet recruiting
      • Shaoxing City First People's Hospital
      • Contact: Zhonghua Chen; Phone Number: +8613867502391; Email: 841135078@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The propofol - alfentanil group（The control group）; 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; General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.
Experimental: The remimazolam and propofol - alfentanil group (The experimental group); 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; General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）	Periprocedural

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of other adverse events	Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force	Periprocedural

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Shaoxing People's Hospital; The Second Affiliated Hospital of Jiaxing University; Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: hypoxia; propofol; fiberoptic bronchoscopy; remimazolam
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Tuberculosis, Pulmonary; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Fentanyl; Propofol; Alfentanil
• Other Study ID Numbers: ZJU2026B0127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No