Correlation Between Neurofilament Light Chain and Remazolam Sensitivity in Elderly Adults

NCT07280663 | Completed Early Phase 1

• 1 other identifier: yuewei20251009
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Age

Keywords

old age; Neuronal filament light chain protein; Remazolane

Outcome Measures

Primary Outcomes (8)

• neurofilament light chain protein

  Differences in level of neurofilament light chain protein

  24 hours

• Loss of consciousness time

  Differences in loss of consciousness time

  24hours

• awakening time

  Differences in awakening time

  24 hours

• Remazolane dosage

  Differences in Remazolane dosage

  24 hours

• Mean Arterial Pressure (MAP)

  Differences in Mean Arterial Pressure (MAP)

  24 hours

• heart rate

  Differences in heart rate

  24 hours

• Electroencephalographic dual frequency index (BIS value)

  Differences in Electroencephalographic dual frequency index (BIS value)

  24 hours

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

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

  24 hours

Secondary Outcomes (1)

• Use of vasoactive drugs

  24 hours

Other Outcomes (2)

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

  24 hours

• BMI

  24 hours

Study Arms (2)

Group with normal cognitive function

EXPERIMENTAL

MMSE scores tweney-seven or more points

Drug: Remazolane

Group with declining cognitive function

EXPERIMENTAL

MMSE scores zero to twenty-seven

Drug: Remazolane

Interventions

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.

Group with declining cognitive function; Group with normal cognitive function

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: October 9, 2025
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

CN (1)