A Phase 4 interventional study of propofol and alfentanil and remimazolam combined with propofol and alfentanil in Pulmonary Infection, Pulmonary Nodule and Phthisis, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 4, Interventional, and Prevention
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.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 360 is above the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: Propofol · Alfentanil
General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.
Drug pages: Remimazolam · Propofol · Alfentanil
General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
Time frame: Periprocedural
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
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame: Periprocedural
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
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Studies of the drugs tested here: Remimazolam · Propofol · Alfentanil
First Affiliated Hospital of Zhejiang University →