Pulmonary InfectionPhase 4NCT07395596
Remimazolam for Bronchoscopy in High-Risk Patients
A Phase 4 study testing propofol and alfentanil and remimazolam combined with propofol and alfentanil in people with Pulmonary Infection and Pulmonary Nodule, run by First Affiliated Hospital of Zhejiang University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Infection, Pulmonary Nodule, Phthisis
- What is being tested?
- propofol and alfentanil and remimazolam combined with propofol and alfentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 9 Feb 2026to Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Class Ⅲ - Ⅳ
- Scheduled for elective painless bronchoscopy -
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310000
+8613515815457, 21618018@zju.edu.cn
- Not yet recruiting
Shaoxing City First People's Hospital
Shaoxing, Zhejiang, 310000
Zhonghua Chen, +8613867502391, 841135078@qq.com
About this study
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
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.
- Being tested
- propofol and alfentanil, remimazolam combined with propofol and alfentanil
- Keywords
- hypoxia, remimazolam, propofol, fiberoptic bronchoscopy
- Medical subject headings
- Tuberculosis, Pulmonary, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol and alfentanilDrug
General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.
remimazolam combined with propofol and alfentanilDrug
General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: remimazolam combined with propofol and alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Measured: Periprocedural
Secondary outcomes (4)
The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）
Measured: 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
Measured: Periprocedural
The area under the curve (AUC) of the patient's mean blood pressure during observation in Post-Anesthesia Care Unit
Measured: Periprocedural
The dosage of vasoactive drugs administered.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start9 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University
- Responsible party
- Principal investigator, Yueying Zheng, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395596
- Sponsor's protocol ID
- ZJU2026B0127
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes