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Correlation Between Neurofilament Light Chain and Remazolam Sensitivity in Elderly Adults

A Study on the Correlation Between the Level of Neurofilament Light Chain Protein and the Sensitivity to Remazolam in Older Adults

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07280663
Enrollment
128
Registered
2025-12-12
Start date
2025-10-09
Completion date
2025-10-09
Last updated
2025-12-12

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

Conditions

Old Age

Keywords

old age, Neuronal filament light chain protein, Remazolane

Brief summary

With the acceleration of population aging, China has entered a stage of deep aging. According to data from the Seventh National Census of Population released in 2021, the proportion of individuals aged 60 or older is 18.70%, with a total number of 264 million, while the proportion of individuals aged 65 or older is 13.50%, with a total number of approximately 190 million. As the proportion of elderly individuals continues to rise, the number of elderly patients undergoing surgical procedures has also increased significantly. Elderly individuals often suffer from multiple chronic diseases, a decline in physiological reserve function, and a reduced tolerance to anesthesia and surgery, presenting new challenges for anesthesiologists. Moreover, cognitive dysfunction is prevalent among the elderly and increases with age . Cognitive dysfunction before surgery is not only closely related to postoperative complications, delirium, further deterioration of cognitive function, and increased mortality, but also leads to longer hospital stays and higher medical expenses after surgery.Therefore, it is of great significance to timely and accurately identify whether the cognitive function of the elderly has been impaired and to actively implement targeted intervention strategies to maintain the health and prognosis of elderly surgical patients, as well as to control the social medical costs.

Detailed description

1.1) To investigate the correlation between the levels of neurofilament light chain protein and the scores obtained from the Mini-Mental State Examination (MMSE). 2\) Investigate the correlation between the levels of neurofilament light chain protein and the sensitivity to remazolam in elderly patients. 3\) Study the factors that influence the sensitivity of remazolane in elderly patients. 2.Methods: One hundred and twenty-eight patients undergoing knee joint replacement were divided into normal cognitive group and cognitive decline group according to MMSE score. 3.MAIN OUTCOME MEASURES: (1) Age, gender, education level, BMI, ASA classification, smoking history, drinking history, cardiovascular disease history, diabetes mellitus history, hyperlipidemia history and COPD history. (2) BP, MAP, HR, degree of saturation of blood oxygen and BIS were measured after entering the room, after the level of spinal anesthesia was stable, when the patient lost consciousness (mascara reflex was lost) after the patient was injected with Rimazolam, and when the patient woke up immediately after the patient stopped taking the drug. (3) The time of consciousness loss (loss of eyelashes reflection) after the injection of rumazine, and the amount of drug injection. (4) How long the patient wakes after stopping the medication. (5) MMSE scores of patients. (6) Take 2 ml cerebrospinal fluid to measure NFL level. 4.The mean ± SD was used to express the measurement data. The difference between the two groups was analyzed by t-test. One-way analysis of variance (ANOVA) was used to compare the data between the two groups.The counting information is represented in examples (percentages) and the comparison of the rates between the two groups is based on a cartesian test. Multivariate Logistic regression analysis was used to analyze the determinants of sensitivity to RZL. The correlation between NFLP and sensitivity to RZL was analyzed by Superman correlation coefficient.P \< 0.5 was significant difference.

Interventions

DRUGRemazolane

Tramazolam via peripheral venous TCI is administered for sedation, with a concentration setting of 0.26 μg/mL. The infusion of tramazolam is stopped once the patient's consciousness has disappeared, which is indicated by the absence of eyelash reflex. The amount of tramazolam used, the time until consciousness disappeared, the time until awakening, and the BIS value are recorded.

Sponsors

Second Hospital of Shanxi Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective knee joint replacements. * Age ≥ 60 years. * ASA rating I \ III.

Exclusion criteria

* Persons who have recently used sedatives or opioids. * Persons who are allergic to narcotic drugs. * People with clotting disorder, infection at the site of the puncture, spinal deformities or spinal disorders. * Those who have been diagnosed with nervous system disorders. * Patients or family members refuse to participate in this study. * Exit research for their own reasons.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)24 hoursIncidence of adverse effects (hypotension, bradycardia, respiratory depression)
Mean Arterial Pressure (MAP)24 hoursDifferences in Mean Arterial Pressure (MAP)
heart rate24 hoursDifferences in heart rate
Electroencephalographic dual frequency index (BIS value)24 hoursDifferences in Electroencephalographic dual frequency index (BIS value)
neurofilament light chain protein24 hoursDifferences in level of neurofilament light chain protein
Loss of consciousness time24hoursDifferences in loss of consciousness time
awakening time24 hoursDifferences in awakening time
Remazolane dosage24 hoursDifferences in Remazolane dosage

Secondary

MeasureTime frameDescription
Use of vasoactive drugs24 hoursUse of vasoactive drugs

Other

MeasureTime frameDescription
BMI24 hoursweight and height will be combined to report BMI in kg/m\^2
Checklist form: Age, gender, education level, , ASA grade, smoking history, drinking history, cardiovascular disease , diabetes mellitus , hyperlipidemia, and COPD24 hours

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026