FindTrial
Sign In

Comparison of the effects of lumbar epidural anesthesia combined with remidazolam or dexmedetomidine sedation on postoperative delirium in elderly patients undergoing lower limb orthopedic surgery: a randomized controlled, double-blind, non-inferiority study

Comparison of the effects of lumbar epidural anesthesia combined with remidazolam or dexmedetomidine sedation on postoperative delirium in elderly patients undergoing lower limb orthopedic surgery: a randomized controlled, double-blind, non-inferiority study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070546
Enrollment
Unknown
Registered
2023-04-15
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Postoperative delirium

Interventions

Remimazolam group:The patient will be given remimazolam for intraoperative sedation.
Dexmedetomidine group:The patient will be given Dexmedetomidine for intraoperative sedation.

Sponsors

Department of Anesthesiology,Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) aged 65 to 90 years old (2)ASA I-III grade (3)undergoing lower limb orthopedic surgery under combined spinal-epidural anesthesia

Exclusion criteria

Exclusion criteria: (1) Preoperative Mini Mental State Examination (MMSE) score<24 (2) Drug or psychotropic substance abuse, including long-term use of steroids and hormonal drugs (3) Severe visual and auditory impairment (4) Preoperative coagulation dysfunction (5) Central nervous system infection, head injury, multiple sclerosis Neurodegenerative lesions or other major neurological disorders other than Alzheimer's disease (AD), (6) severe psychological disorders, (7) preoperative use of remimazolam or dexmedetomidine, (8) individuals with a history of allergy to remimazolam or dexmedetomidine.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium;—

Secondary

MeasureTime frame
Perioperative blood pressure;Perioperative heart rate;—

Countries

China

Contacts

Public ContactXu Lin

Department of Anesthesiology,Qingdao Municipal Hospital, No. 5 Donghai Middle Road, Shinan District, Qingdao, Shandong, China

linxu_green@126.com+86 18678951375

Outcome results

None listed

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