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Exploring the Median Effective Dose of Remimazolam for Procedural Sedation During Hip Arthroplasty: Impact of Frailty on ED50

Exploring the Median Effective Dose of Remimazolam for Procedural Sedation During Hip Arthroplasty: Impact of Frailty on ED50

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113622
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Hip Fracture

Interventions

Non-frail patients:Remidazolam
Frail patients:Remidazolam

Sponsors

The First Affiliated Hospital of Shan Tou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective hip arthroplasty under combined spinal-epidural anesthesia; 2. Age>=18 years, regardless of gender; 3. ASA physical status classification of I to III; 4. BMI between 15 and 30 kg/m^2; 5. Written informed consent obtained from the patient or the patient's legal representative.

Exclusion criteria

Exclusion criteria: 1. Inability to complete the pre-operative Mini-Mental State Examination (MMSE) or an MMSE score below the threshold for the corresponding education level (No formal education: <=17; Primary school: <=20; Secondary school: <=22; University: <=23). 2. Pre-existing central nervous system diseases (including dementia, Parkinson's disease, or severe cerebrovascular disease with residual sequelae). 3. History of taking anxiolytic or antidepressant medication. 4. History of drug or alcohol dependence, or severe visual or hearing impairment. 5. Severe hepatic or renal dysfunction. 6. Severe respiratory or cardiovascular/cerebrovascular diseases. 7. Contraindications to neuraxial anesthesia (e.g., use of anticoagulant medications or coagulopathy, spinal diseases, patient refusal, etc.). 8. Known allergy to the drugs used in the study.

Design outcomes

Primary

MeasureTime frame
Effective Sedation;

Countries

China

Contacts

Public ContactZeting Qiu

The First Affiliated Hospital of Shan Tou University Medical College

doctorqiuzt@gmail.com+86 13580546462

Outcome results

None listed

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