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NCT Number: NCT06542978

Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery

Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).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 elective gastrointestinal surgery in AICU.

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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 and older

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.Age ≥ 65 years old,gender not limited
  • 2.ASA classification Ⅱ ~ Ⅳ
  • 3.Elective gastrointestinal general anesthesia surgery

Exclusion criteria

  • 1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
  • 2.Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
  • 3.Delirium on admission or pre-operative delirium, brain injury
  • 4.Severely infected person
  • 5.Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
  • 6.Severe hearing or vision impairment

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 ,Day 4, Day 5, Day 6,Day 7 after surgery

    Postoperative delirium was assessed using the CAM-ICU scale.The RASS score (The Richmond Agitation-Sedation Scale) was used to assess arousal. When the patient's RASS score is not -4 /-5, delirium evaluation can continue considering the patient's wakefulness status.CAM-ICU scale contains four features (Feature 1, Feature 2, Feature 3, and Feature 4). Delirium can be diagnosed when the patient is positive for features 1, 2, 3, or 4.

Secondary outcomes

  1. Blood Markers

    Time frame: half hour, 6hours, 24hours and 48hours after transfer to aicu

    Serum Tau proteomic analysis and CRP, IL-6, and TNF-ɑ were recorded

  2. Sleep quality

    Time frame: 8:00 to 10:00 every morning for the first three days after surgery

    The Chinese version of the Richards-Campbell Sleep Quality Scale Score (RCSQ) was used to evaluate sleep quality. RCSQ scoring average for five projects, including 0 ~ 25 points on behalf of the poor quality of sleep, on behalf of the sleep quality of 76 ~ 100 points; The higher the score says sleep quality, the better

  3. The incidence of pain

    Time frame: 6hours, 24hours, 48hours after surgery

    Mark a 0-10cm horizontal line on the paper with a ruler, and determine the score in millimeters (mm). The score range is 0-100mm, and the higher the score, the greater the pain intensity; No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), severe pain (75-100 mm).

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Oct 28, 2024

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

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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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