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Application of electro-encephalographic monitoring bundle anti-inflammatory therapy in the prophylactic treatment of postoperative delirium in elderly patients with hip fracture

Comprehensive strategies for the prevention and treatment of perioperative pain and delirium in elderly patients - Application of electro-encephalographic monitoring bundle anti-inflammatory therapy in the prophylactic treatment of postoperative delirium in elderly patients with hip fracture

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074303
Enrollment
Unknown
Registered
2023-08-03
Start date
2023-08-10
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

delirium

Interventions

anti-inflammatory therapy group:anti-inflammatory drugs
control group:saline

Sponsors

Beijing Jishuitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: a.age over 65 years old b. ASA classification Grade I-III c. Patients participate voluntarily and sign informed consent forms d. Elderly orthopedic unit assessed by anesthesia; d.According to the modified comprehensive score formula of delirium index DELi, the prediction probability of delirium > 50% was used to screen the high-risk patients with delirium.

Exclusion criteria

Exclusion criteria: a. Patients with a history of psychosis or chronic use of psychotropic substances (severe dementia, schizophrenia), a history of chronic analgesia, or alcoholism; b. If there is a cerebrovascular accident such as stroke or TIA within 3 months; c. Participate in other clinical drug investigators within the past 30 days; d. Patients with hearing and visual impairments; Patients with communication difficulties were unable to complete cognitive function tests. ; e. Known preoperative left ventricular ejection fraction of less than 30%, sick sinus syndrome, severe sinus bradycardia (50 beats per minute), or second-degree or higher atrioventricular block without pacemaker; d. Severe liver dysfunction (Child-Pugh Class C) (Severe liver dysfunction: ALT, binding bilirubin, AST, ALP, total bilirubin one of them > 2 times the upper limit of normal); e. severe renal insufficiency, Cr clearance rate > 30 ml/min, Scr > 443µmol/L(preoperative dialysis);h. Patients known to be allergic to flurbiprofen and contraindicated for the treatment of perioperative pain during coronary artery bypass surgery (CABG); Patients with asthma, hives, or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. Patients with a history of gastrointestinal bleeding or perforation after use of NSaids. Patients with active gastrointestinal ulcers/bleeding or previous recurrent ulcers/bleeding. Patients with severe heart failure, hypertension. Patients who are using enoxacin, Lomefloxacin, norfloxacin. Dexamethasone should be contraindicated in patients with allergic history of adrenocortical hormones; Dexamethasone should not be used in patients with thrombosis, gastric and duodenal ulcers, psychosis, abnormal electrolyte metabolism, myocardial infarction, visceral surgery, and glaucoma. Patients who are allergic to dexmedetomidine. i. Patients with coronary balloon dilatation or stent implantation, aspirin =625mg/d, and withdrawal time before clopidogrel anticoagulation 1.7 APTT exceeds the normal value 4s, platelet < 50×109. Lumbar anesthesia and cerebrospinal fluid extraction are prohibited.

Design outcomes

Primary

MeasureTime frame
Delirium index (DELi);Confusion Assessment Method (Short CAM);C-reactive protein (CRP);Calcification binding protein S100-beta (S100B);Richmond Agitation Sedation Scale (RASS);Delirium Rating Scales (DRS-R-98);Neuron-specific enolase (NSE);Montreal Assessment of Cognitive Function (MoCA);Hospital Anxiety and Depression Scale(HADS);Fatigue, Endurance, Walking, Illness and Weight Loss Index Scale (FRAIL);Anxiety-depression index;

Secondary

MeasureTime frame
Pain index;Numerical rating scale (NRS);Critical Care Pain Observation Tool (CPOT);

Countries

China

Contacts

Public ContactZhang WenChao

Department of Anesthesiology, Beijing Jishuitan Hospital,XiCheng Distirict, Beijing, China

wenchaozhang116@163.com+86 139 1099 1465

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026