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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Age ≥ 65 years old,gender not limited

2.ASA classification Ⅱ ~ Ⅳ

3.Elective gastrointestinal general anesthesia surgery

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: 40Hz stimulation groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence of postoperative delirium

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.

Time frame
Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery

Secondary outcomes

1

Blood Markers

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

Time frame
half hour, 6hours, 24hours and 48hours after transfer to aicu
2

Sleep quality

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

Time frame
8:00 to 10:00 every morning for the first three days after surgery
3

The incidence of pain

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).

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

Other outcomes

Sponsors and contacts

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