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The Efficacy and Safety of Remimazolam Tosilate versus Dexmedetomidine in Outpatients Undergoing Flexible Bronchoscopy: A prospective, randomized, blind, non-inferiority trial

The Efficacy and Safety of Remimazolam Tosilate versus Dexmedetomidine in Outpatients Undergoing Flexible Bronchoscopy: A prospective, randomized, blind, non-inferiority trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058682
Enrollment
Unknown
Registered
2022-04-14
Start date
2022-04-04
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Anesthesiology

Interventions

RR:remimazolam tosilate-remifentanil
DR:dexmedetomidine- remifentanil

Sponsors

Liaocheng People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: outpatients undergoing FB with moderate sedation; aged 45 to 65 years; American Society of Anesthesiologists (ASA) ?-?; procedure time is no longer than 30 min; oxygen saturation (SpO2) > 90% in room air

Exclusion criteria

Exclusion criteria: history of known allergy to local anesthetics, RF, Dex, midazolam, propofol or RT; pre-existing lung diseases (such as chronic obstructive pulmonary disease (COPD), respiratory failure and asthma); severe sleep apnea syndrome (apnea-hypopnea index >40); body mass index (BMI) >30 kg/m2; communication barrier; history of neuropsychiatric disorders, cerebrovascular diseases, abnormalities of renal or hepatic function; nasopharyngeal surgery; second- or third-degree atrioventricular block; bradycardia (heart rate (HR) <60 beats per minute); drugs or alcohol abuse; participating in other clinical trials nearly 3 months.

Design outcomes

Primary

MeasureTime frame
the successful completion rate of procedure;

Secondary

MeasureTime frame
time metrics, hemodynamics;intubating conditions, lowest oxygen saturation, severity of coughing,;number of remedies, total dose of fentanyl, RF, RT and Dex, incidence of dreaming,;patient and bronchoscopist satisfactions, willingness to the repeat bronchoscopy;

Countries

China

Contacts

Public ContactQing Lv

Liaocheng People's Hospital

13869530842@163.com+86 13869530842

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026