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The effect of remimazolam sedation on postoperative delirium in elderly patients undergoing hip arthroplasty under spinal anesthesia

The effect of remimazolam sedation on postoperative delirium in elderly patients undergoing hip arthroplasty under spinal anesthesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093696
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-10
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

anaesthesia

Interventions

Remimazolam group:Administer a loading dose of remimazolam at 0.10 mg/kg, followed by a maintenance dose of 0.20 mg/kg/h. Dynamically adjust with a dose gradient of 0.05mg/kg/h based on the level of s
Control group:Administer a loading dose of 0.9% sodium chloride injection at 0.10 ml/kg, followed by a maintenance dose of 0.20 ml/kg/h.

Sponsors

Affiliated Hospital of Jiangsu University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients scheduled for elective total hip arthroplasty due to hip fracture, regardless of gender, aged =65 years, with a body mass index (BMI) of 18~30 kg/m², and ASA classification I~III.

Exclusion criteria

Exclusion criteria: Patients with obvious respiratory or circulatory dysfunction, abnormalities in liver or kidney function, a Mini-Mental State Examination (MMSE) score <24 one day before surgery, pre-existing major neurological diseases such as Alzheimer's disease or dementia, psychiatric disorders such as depression or anxiety, potential or history of drug abuse or alcohol dependency, inability to cooperate (e.g., complete blindness, severe hearing loss, aphasia), allergies or contraindications to benzodiazepines or local anesthetics, and contraindications to spinal anesthesia.

Design outcomes

Primary

MeasureTime frame
The incidence of delirium within three days after surgery;

Secondary

MeasureTime frame
Delirium Subtypes;heart rate;Mean Arterial Pressure;The quality of sleep;postoperative pain score;Patient Satisfaction with Anesthesia;Blood Loss;bispectral index;Incidence of Adverse Reactions;Utilization of Vasoactive Drugs;

Countries

China

Contacts

Public ContactWu Jin

Affiliated Hospital of Jiangsu University

wujin914@hotmail.com+86 159 0528 1553

Outcome results

None listed

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