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Safety and efficacy of remimazolam combined with alfentanil in deep sedation during fiberoptic bronchoscopy: a prospective, randomized controlled trial

Safety and efficacy of remimazolam combined with alfentanil in deep sedation during fiberoptic bronchoscopy: a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083383
Enrollment
Unknown
Registered
2024-04-23
Start date
2024-04-25
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

elderly patients undergoing fiberoptic bronchoscopy

Interventions

group R:Alfentanil was first injected with a micropump for 10 µg/kg, and the first dose of remazolam was 0.2mg/kg by micropump injection after 30 seconds. The target depth of sedation was set as MOAA/
group P:Alfentanil was first injected with a micropump for 10 µg/kg, and the first dose of propofol was 1.5mg/kg by micropump injection after 30 seconds. The target depth of sedation was set as MOAA/

Sponsors

Lishui People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Aged 65-80 years, BMI 18.5-27.9kg/m2; ? ASA (American Society of anesthesiologists) grade II ~ III elderly patients undergoing fiberoptic bronchoscopy; ? The patients and their families knew the purpose of this study and voluntarily signed a written informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with neurological or psychiatric diseases or communication disorders before operation; ? Preoperative diagnosis was respiratory failure (PaO2 < 60mmhg); ? New York Heart Association (NYHA) cardiac function class III or IV; ? Patients with suspected difficult airway; ? Those who have been allergic to benzodiazepines or propofol in the past, and those who have taken sedative drugs for a long time; ? Patients with severe arrhythmias, such as second or third degree atrioventricular block or significant bradycardia (HR<50 BPM).

Design outcomes

Primary

MeasureTime frame
Hypoxemia;

Secondary

MeasureTime frame
severe hypoxemia ;Minimum SpO2 during inspection;Maximum cough rating;Success rate of first dose sedation;Sedation success rate;Number of cases of rescue sedation;Additional sedation times;

Countries

China

Contacts

Public ContactDuan Gongchen

Lishui People's Hospital

981225178@qq.com+86 189 5709 3030

Outcome results

None listed

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