Anesthesia, Elderly, Postoperative Delirium
Conditions
Brief summary
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
DEVICE40Hz 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.
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative delirium | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood Markers | half hour, 6hours, 24hours and 48hours after transfer to aicu | Serum Tau proteomic analysis and CRP, IL-6, and TNF-ɑ were recorded |
| Sleep quality | 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 |
| The incidence of pain | 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). |
Countries
China
Contacts
Primary ContactZhang jiaqiang
Outcome results
None listed