Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endotracheal Tumour | — | UNRESOLVED | — |
| Lymphadenectasis | — | UNRESOLVED | — |
| Phthisis | — | UNRESOLVED | — |
| Pulmonary Infection | — | UNRESOLVED | — |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| propofol and alfentanil | Drug | — | UNRESOLVED |
| remimazolam combined with propofol and alfentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The propofol - alfentanil group（The control group）
- description
- 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.
- interventionNames
- Drug: propofol and alfentanil
- type
- EXPERIMENTAL
- label
- The remimazolam and propofol - alfentanil group (The experimental group)
- description
- 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.
- interventionNames
- Drug: remimazolam combined with propofol and alfentanil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available