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Comparative Study on the Preventive Effects of Different Administration Timings of Dexmedetomidine on Postoperative Delirium in Elderly Patients

Comparative Study on the Preventive Effects of Different Administration Timings of Dexmedetomidine on Postoperative Delirium in Elderly Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114299
Enrollment
Unknown
Registered
2025-12-10
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Lower extremity fracture in the elderly

Interventions

Preoperative Dexmedetomidine Group:Infusion is initiated 15 minutes before neuraxial anesthesia puncture at a dose of 0.5 µg/kg, with a duration of at least 10 minutes.
Intraoperative Dexmedetomidine Group:Infusion is initiated 15 minutes before skin incision at a dose of 0.5 µg/kg, with a duration of at least 10 minutes.
Control Group:An equivalent volume of 0.9% sodium chloride injection was infused concurrently, with the infusion rate and duration matching those of the experimental group.

Sponsors

Rugao People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients scheduled to undergo lower limb fracture surgery under neuraxial anesthesia; (2) Age >= 65 years; (3) Ability to complete MMSE, MoCA, and VAS assessments; (4) Both the patient and family members provide written informed consent to participate in the study; (5) ASA physical status classification ?–?.

Exclusion criteria

Exclusion criteria: (1) The patient or family members refuse to participate in the study; (2) Comorbid organic brain diseases, such as traumatic brain injury, intracranial hematoma, or congenital brain malformations; (3) Patients with dementia or known psychiatric disorders; (4) Individuals with aphasia or hearing impairment; (5) Patients with a known allergy to the study drug; (6) Preoperative severe sinus bradycardia (<50 beats per minute); (7) Patients with hepatic dysfunction (Child-Pugh class B or C) or renal dysfunction (uremic stage or requiring preoperative dialysis); (8) Patients who do not sign the informed consent form or are lost to follow-up.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 3 days after surgery;

Secondary

MeasureTime frame
Mini-Mental State Examination Score;Leeds Sleep Evaluation Questionnaire;Visual Analog Scale (VAS) pain score;Activities of Daily Living Score;Cerebral function parameters (Cerebral Oxygen Saturation, rSO?, and Bispectral Index, BIS);Hemodynamics;

Countries

China

Contacts

Public ContactXiaolin Yang

Rugao People's Hospital

yangxiaolinrugao@163.com+86 138 6192 7678

Outcome results

None listed

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