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Clinical study of the effects of remazolam besylate on cognitive function

Clinical study of the effect of remazolam besylate on postoperative cognitive function in elderly patients with preoperative cognitive impairment

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060795
Enrollment
Unknown
Registered
2022-06-11
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Cognitive dysfunction

Interventions

Group D:Dexmedetomidine sedation
Group R:Remazolam sedation

Sponsors

Qujing First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients who intend to undergo elective hip surgery; 2. Proposed lumbar hard combination anesthesia or other spinal canal anesthesia; 3. Aged >= 70 years, regardless of sex; 4. ASA grade I-III, NYHA grade I-III; 5. Preoperative MMSE score below normal (overall score of 30 points, normal cut-off criteria are: illiterate > 17 points, primary school > 20 points, junior high school and above > 24 points) or have one of the following high risk factors for dementia: subjective memory loss stated by the patient or his family, family history of dementia, educational attainment is illiterate or primary school, renal insufficiency, frail scale score of >= 3 or BMI <= 17.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to spinal anesthesia: lumbar deformity, lumbar disc herniation, lumbar fracture, lumbar fracture after internal fixation, central nervous system infection, coagulation dysfunction (PT prolonged for more than 3 seconds, APTT prolonged for more than 10 seconds), platelet 180 mmHg and/or DBP > 110 mmHg, fasting blood glucose > 10 mmol/L, severe organ dysfunction; 8. Postoperative ICU need to be sent to continue treatment; 9. Intraspinal puncture is unsuccessful or general anesthesia due to surgical needs; 10. Other conditions that investigators judge are not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
mini-mental state examiniation;

Secondary

MeasureTime frame
interleukin-6;

Countries

China

Contacts

Public ContactYixuan Ouyang

Qujing First People's Hospital of Yunnan Province

459620352@qq.com+86 18908749168

Outcome results

None listed

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