Remimazolam for Bronchoscopy in High-Risk Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA Class Ⅲ - Ⅳ

Scheduled for elective painless bronchoscopy -

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • propofol and alfentanil

    Drug

    General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.

  • remimazolam combined with propofol and alfentanil

    Drug

    General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: The propofol - alfentanil group(The control group)Active comparator 1 intervention
Group B: The remimazolam and propofol - alfentanil group (The experimental group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of hypoxia(75% ≤ SpO2 < 90% for <60 s)

Time frame
Periprocedural

Secondary outcomes

1

The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)

Time frame
Periprocedural
2

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
3

The area under the curve (AUC) of the patient's mean blood pressure during observation in Post-Anesthesia Care Unit

Time frame
Periprocedural
4

The dosage of vasoactive drugs administered.

Time frame
Periprocedural

Other outcomes

1

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

Sponsors and contacts

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First Affiliated Hospital of Zhejiang University

Lead sponsor

Shaoxing People's Hospital

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

The Second Affiliated Hospital of Jiaxing University

Collaborator