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

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 Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Elderly; Anesthesia
• Intervention / Treatment: Device: 40Hz stimulation

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang jiaqiang; Phone Number: 037165580728; Email: hnmzxh@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan People's Hospital
      • Contact: Zhang jiaqiang; Phone Number: 037165580728; Email: hnmzxh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; After admission to AICU, the control group was not stimulated at 40Hz ;
Experimental: 40Hz stimulation group; After admission to AICU, the experimental group was stimulated at 40Hz for 6h;	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Markers	Serum Tau proteomic analysis and CRP, IL-6, and TNF-ɑ were recorded	half hour, 6hours, 24hours and 48hours after transfer to aicu
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	8:00 to 10:00 every morning for the first three days after surgery
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).	6hours, 24hours, 48hours after surgery

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: August 3, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: Henan FYX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No