The Effect of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients

Not Applicable

Recruiting

• Conditions: Postoperative Delirium; Elderly; Anesthesia
• Interventions: Device: 40Hz stimulation

• Registration Number: NCT06542978
• Lead Sponsor: Henan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-07-23
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-03
• Study First Posted: 2024-08-07
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40Hz stimulation group	40Hz stimulation	After admission to AICU, the experimental group was stimulated at 40Hz for 1h;

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Henan People's Hospital; 🇨🇳 Zhengzhou, Henan, China