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Effect of sodium oxybate on sleep quality and neuro-cognitive funtion of elderly patients

Effect of sodium oxybate on sleep quality and neuro-cognitive funtion of elderly patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078594
Enrollment
Unknown
Registered
2023-12-13
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

postoperative neurocognitive disorder

Interventions

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >=65 years; 2. Undergo elective orthopedic surgery with anticipated surgical duration longer than 2 hours; 3. ASA score levels I to III; 4. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe hearing and visual impairment, unable to read; 2. Patients with severe consciousness disorder or inability to communicate (coma, deep dementia or language disorder) or MMSE score <20 or cognitive dysfunction before surgery; 3. Preoperative psychiatric diseases (schizophrenia, mania, bipolar disorder, insanity, etc.); 4. Preoperative history of epilepsy, Parkinson's syndrome or myasthenia gravis; 5. Known preoperative left ventricular ejection fraction of less than 30%, pathological sinus syndrome, severe sinus bradycardia (< 50 beats/min), or second degree or larger atrioventricular block without pacemaker; 6. Severe liver dysfunction (Child-Pugh grade C); 7. Severe renal insufficiency (dialysis prior to surgery); 8. Patients expected to be admitted to ICU after surgery; 9. Patients with known allergy to the active ingredient of sodium oxybate injection, or contraindications to sodium oxybate use such as hypokalemia, ethanol intoxication, and severe cardiac insufficiency.

Design outcomes

Primary

MeasureTime frame
Confusion Assessment Method-ICU;visual analogue scale for pain;

Secondary

MeasureTime frame
delirium rating scale-98;numerical rating scale for sleep quality;Mini-mental State Examination;

Countries

China

Contacts

Public ContactCui Meiying

Shengjing Hospital of China Medical University

cmynana@163.com+86 189 4025 4482

Outcome results

None listed

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