Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 40Hz stimulation.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium, Anesthesia, Elderly. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 40Hz stimulation
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 outcome measures
- The incidence of postoperative delirium [Time frame: Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery]
Secondary outcome measures (3)
- Blood Markers [Time frame: half hour, 6hours, 24hours and 48hours after transfer to aicu]
- Sleep quality [Time frame: 8:00 to 10:00 every morning for the first three days after surgery]
- The incidence of pain [Time frame: 6hours, 24hours, 48hours after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Henan People's Hospital — Zhengzhou
Identifiers
NCT: NCT06542978 · Henan FYX