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Effects of Different Sedation Strategies on Perioperative Stress Response and Brain Function in Elderly Patients with Moderate to Severe Lower Extremity Trauma

Effects of Different Sedation Strategies on Perioperative Stress Response and Brain Function in Elderly Patients with Moderate to Severe Lower Extremity Trauma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125185
Enrollment
Unknown
Registered
2026-05-22
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Elderly trauma

Interventions

Dexmedetomidine TCI Group (DEX Group): :Target effect-site concentration (Ce) set at 0.4–0.6 ng/ml.
Remimazolam TCI Group (REM Group):Target plasma concentration (Cp) set at 0.5–0.8 µg/ml
Biofeedback Relaxation Group (BIO Group):Receive 5 minutes of standardized training (abdominal breathing + muscle relaxation) before surgery
Control Group (CTRL Group):TCI pump loaded with sterile saline

Sponsors

Affiliated Chenggong Hospital of Xiamen University (73rd Army Group Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years. 2. Lower extremity trauma with a Lower Extremity Trauma Score (LETS) >= 4 (indicating moderate to severe injury). 3. Anesthesia method: combined spinal anesthesia and peripheral nerve block.

Exclusion criteria

Exclusion criteria: 1. Contraindications to MRI (e.g., presence of metallic implants, claustrophobia, etc.); 2. Severe baseline cognitive impairment (Montreal Cognitive Assessment, MoCA score < 18); 3. Severe liver or kidney dysfunction (Child-Pugh class C or estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m^2); 4. Long-term use of sedatives, analgesics, or psychotropic drugs (e.g., benzodiazepines, opioids); 5. Hemodynamic instability requiring high-dose vasoactive agents for maintenance; 6. Contraindications to neuraxial anesthesia.

Design outcomes

Primary

MeasureTime frame
Changes in Brain Region Activation (fMRI Z-Scores);

Secondary

MeasureTime frame
Visual Analog Scale;Neuroendocrine and Immune Stress Indicators:Cortisol,Epinephrine,Norepinephrine;

Countries

China

Contacts

Public ContactPengxia Wang

Affiliated Chenggong Hospital of Xiamen University(The 73rd Army Group Hospital, PLA)

1843149196@qq.com+86 188 3418 5856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026