Comparison of the safety of remazolam besylate and midazolam combined with sufentanil in painless fiberoptic bronchoscopy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500113068

Enrollment

Unknown

Registered

2025-11-24

Start date

2025-08-19

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Observation Group:Administer a single dose of intravenous injection of 5mg remifentanil besylate, followed by an additional 2.5mg as needed each time, with a maximum dose of 0.2mg/kg, in combination w

Control group:Conventional single intravenous injection of 0.05-0.075 mg/kg midazolam, with a total dose not exceeding 3 mg for adults under 70 years old and 2 mg for those over 70 years old, in combi

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Scheduled for painless fiberoptic bronchoscopy; 2. Able to understand and sign the informed consent form, aged between 18-75 years, gender (not limited); 3. ASA classification I-III; 4. No cognitive impairment, mental disorders, or communication barriers; 5. Have not participated in other clinical trials within 3 months prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation; 2. Contraindications for routine (bronchial) endoscopy procedures, severe liver and kidney dysfunction, coagulation disorders, and gastric retention due to full stomach or gastrointestinal obstruction; 3. Life-threatening circulatory and respiratory diseases that are not adequately controlled (such as acute coronary syndrome, uncontrolled severe hypertension, severe arrhythmia, severe heart failure, recent acute myocardial infarction, and acute asthma exacerbation, etc.); 4. Patients allergic to midazolam or remimazolam besylate, or those who have developed delirium after previous use of such drugs; 5. Patients with significant neuropsychiatric symptoms such as stroke, hemiplegia, and depression; 6. Patients with emergency airway conditions such as severe airway stenosis, active bleeding, and foreign body obstruction.

Design outcomes

Primary

Measure	Time frame
Richmond Agitation-Sedation Scale;	—

Secondary

Measure	Time frame
Respiratory depression;choke cough;Low blood pressure;	—

Countries

China

Contacts

Public ContactLi Fengping

Ankang Hospital of Traditional Chinese Medicine

904697230@qq.com+86 915 231 0390

Outcome results