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| Name | Class |
|---|---|
| Shaoxing People's Hospital | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol and alfentanil | Drug | General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoxia(75% ≤ SpO2 < 90% for <60 s) | Periprocedural |
| Measure | Description | 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueying Zheng | Contact | +8613777408863 | 1507128@zju.edu.cn | |
| Yeke Zhu | Contact | +8613515815457 | 21618018@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital, Zhejiang University School Of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| remimazolam combined with propofol and alfentanil | Drug | General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil. |
|
| 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 |
| Shaoxing City First People's Hospital | Not yet recruiting | Shaoxing | Zhejiang | 310000 | China |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |