Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- The incidence of postoperative delirium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
40Hz stimulation group
After admission to AICU, the experimental group was stimulated at 40Hz for 6h;
Intervention: 40Hz stimulation (Device)
Control group
After admission to AICU, the control group was not stimulated at 40Hz ;
Outcomes
Primary Outcomes
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
- Blood Markers(half hour, 6hours, 24hours and 48hours after transfer to aicu)
- The incidence of pain(6hours, 24hours, 48hours after surgery)
- Sleep quality(8:00 to 10:00 every morning for the first three days after surgery)