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NCT Number: NCT07280663

Correlation Between Neurofilament Light Chain and Remazolam Sensitivity in Elderly Adults

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.

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Key information

Conditions

Old Age

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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).

  • Investigate the correlation between the levels of neurofilament light chain protein and the sensitivity to remazolam in elderly patients.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remazolane

Drug

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.

Primary outcomes

  1. neurofilament light chain protein

    Time frame: 24 hours

    Differences in level of neurofilament light chain protein

  2. Loss of consciousness time

    Time frame: 24hours

    Differences in loss of consciousness time

  3. awakening time

    Time frame: 24 hours

    Differences in awakening time

  4. Remazolane dosage

    Time frame: 24 hours

    Differences in Remazolane dosage

  5. Mean Arterial Pressure (MAP)

    Time frame: 24 hours

    Differences in Mean Arterial Pressure (MAP)

  6. heart rate

    Time frame: 24 hours

    Differences in heart rate

  7. Electroencephalographic dual frequency index (BIS value)

    Time frame: 24 hours

    Differences in Electroencephalographic dual frequency index (BIS value)

  8. Incidence of adverse effects (hypotension, bradycardia, respiratory depression)

    Time frame: 24 hours

    Incidence of adverse effects (hypotension, bradycardia, respiratory depression)

Secondary outcomes

  1. Use of vasoactive drugs

    Time frame: 24 hours

    Use of vasoactive drugs

Other outcomes

  1. Checklist form: Age, gender, education level, , ASA grade, smoking history, drinking history, cardiovascular disease , diabetes mellitus , hyperlipidemia, and COPD

    Time frame: 24 hours

  2. BMI

    Time frame: 24 hours

    weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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