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NCT Number: NCT06522087

The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients.

Delirium is an acute confusional state, it is a sign of acute encephalopathy, also known as acute brain failure, acute brain dysfunction or mental state changes.Postoperative delirium can cause post-traumatic stress disorder, affects patients' quality of life, extend the length of hospital stay, increased hospitalization cost, and is closely relative to short-term and long-term mortality after surgery. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing hip and knee replacement.

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Key information

Conditions

Postoperative Delirium Anesthesia Confusion Delirium Elderly Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1.65-85 years old, gender not limited 2.General anesthesia unilateral total hip replacement surgery or unilateral total knee replacement 3.ASA classification I-III 4.No drugs for mental and central nervous system diseases were used before surgery 5.Preoperative MMSE score illiterate > 17 points, primary > 20 points, junior high school and above > 24 points 6.Obtaining informed consent

Exclusion criteria

  • Severe liver and kidney dysfunction
  • here were mental and nervous system diseases before operation
  • Have a history of alcoholism, long-term use of sedative or analgesic
  • A history of a delirium and other reasons are reluctant to cooperate
  • Massive blood loss and blood transfusion during operation, prolonged operation time

Treatment and study plan

40Hz stimulation

Device

Exogenous 40HZ stimulation is a physical intervention that can drive oscillations in the gamma range, and the oscillations and pulses caused at the corresponding frequency can lead to a significant reduction in β-amyloid, reverse tau hyperphosphorylation, and thereby improve the cognitive function of patients.

Primary outcomes

  1. The incidence of postoperative delirium

    Time frame: Day 1, Day 2, Day 3 after surgery

    Postoperative delirium was assessed by CAM scale.The diagnosis of delirium mainly depends on four characteristics: 1 acute fluctuating course; 2 attention disorder; 3 thinking disorder; 4 change of consciousness level. At the same time, 1 and 2, and 3 or 4 can be used to diagnose delirium.

Secondary outcomes

  1. Blood Markers

    Time frame: Preoperative and postoperative 1 d and 2 d

    Serum Tau proteomic analysis and CRP, IL-6, and B cell levels were recorded

  2. The incidence of postoperative nausea and vomiting

    Time frame: Day 1, Day 2, Day 3 after surgery

    Follow up patients for nausea and vomiting

  3. Sleep quality

    Time frame: Day 1, day 2, day 3 after surgery

    Sleep quality was assessed using a sleep quality scale(QS),(0: no effect on sleep 1: sleep in and out of sleep at night 2: sleep in and out of sleep unable to fall asleep 3: light sleep but unable to fall asleep 4: unable to fall asleep at all)

  4. The incidence of pain

    Time frame: Day 1, day 2, day 3 after surgery

    NRS is a dotted ruler from 0 to 10. 0 means no pain, and 10 means unbearable pain. The patient chooses a number from above to describe the pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang jiaqiang

CONTACT

[email protected]

037165580728

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Aug 28, 2024

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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