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Efficacy and safety of remimazolam combined with alfentanil in elderly patients undergoing diagnostic bronchoscopy

Efficacy and safety of remimazolam combined with alfentanil in elderly patients undergoing diagnostic bronchoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085680
Enrollment
Unknown
Registered
2024-06-15
Start date
2024-06-15
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Respiratory diseases

Interventions

Group MAP:Midazolam 0.045mg/kg + Afentanil 18mg/kg+ propofol titrated to the target sedation depth
Group RAP:Remazolam 0.135mg/kg+ afentanil 18mg/kg+ propofol titrated to the target sedation depth
Group RA:Ramazolam 0.135mg/kg+ afentanil 18mg/kg+ ramazolam titrated to target sedation depth

Sponsors

Beilun People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range between 60-85 years; 2. ASA grade I-III; 3. No other serious systemic comorbidities; 4. Be conscious and able to cooperate with the examination and treatment; 5. The patient gives informed consent and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. ASA classification greater than grade III; 2. Perennial alcoholism, long-term use of drugs affecting mental status (e.g., sedatives) and monoamine oxidase inhibitors; 3. Comorbid severe liver dysfunction (e.g. Child-Pugh class C) or abnormal renal function (e.g. preoperative dialysis); 4. Comorbid psychiatric or psychological disorders resulting in impaired cognitive function; 5. Those with bronchial asthma, respiratory depression and myasthenia gravis and hypersensitivity; 6. Cardiac arrhythmia, preoperative left ventricular ejection fraction less than 30%, sick sinus node syndrome, severe sinus bradycardia (< 50 beats/minute) or atrioventricular block of degree II and above with pacemaker.

Design outcomes

Primary

MeasureTime frame
VAS score of cough response;Sedation success rate;

Secondary

MeasureTime frame
mean arterial pressure;heart rate;Pulse oxygen saturation;end-expiratory carbon dioxide (ECO2);operator satisfaction;recall of intraoperative pain at postoperative follow-up;extra sleep after surgery;Patient satisfaction;Patient's willingness to be re-examined;

Countries

China

Contacts

Public ContactWu Qiuyue

Beilun People's Hospital

1195983036@qq.com+86 137 3600 4721

Outcome results

None listed

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