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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07395596
- Acronym / sponsor ID
- ZJU2026B0127
- Keywords
- hypoxia, remimazolam, propofol, fiberoptic bronchoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The propofol - alfentanil group（The control group） | Active comparator | Drug: propofol and alfentanilIn 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. |
| The remimazolam and propofol - alfentanil group (The experimental group) | Experimental | Drug: remimazolam combined with propofol and alfentanilThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Class Ⅲ - Ⅳ
- Scheduled for elective painless bronchoscopy -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol and alfentanilGeneral anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil. | Drug | The propofol - alfentanil group（The control group） |
| remimazolam combined with propofol and alfentanilGeneral anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil. | Drug | The remimazolam and propofol - alfentanil group (The experimental group) |
Primary outcome
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Time frame: Periprocedural
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueying Zheng (+8613777408863, 1507128@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s） (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.