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

NCT06542978 | Recruiting

• 1 other identifier: Henan FYX
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Anesthesia; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood Markers

  half hour, 6hours, 24hours and 48hours after transfer to aicu

• Sleep quality

  8:00 to 10:00 every morning for the first three days after surgery

• The incidence of pain

  6hours, 24hours, 48hours after surgery

Study Arms (2)

40Hz stimulation group

EXPERIMENTAL

After admission to AICU, the experimental group was stimulated at 40Hz for 6h;

Device: 40Hz stimulation

Control group

NO INTERVENTION

After admission to AICU, the control group was not stimulated at 40Hz ;

Interventions

40Hz stimulation DEVICE

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.

40Hz stimulation group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years old,gender not limited
• ASA classification Ⅱ \~ Ⅳ
• Elective gastrointestinal general anesthesia surgery

You may not qualify if:

• History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
• Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
• Delirium on admission or pre-operative delirium, brain injury
• Severely infected person
• Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
• Severe hearing or vision impairment

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan People's Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhang jiaqiang

CONTACT

037165580728; hnmzxh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 7, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-08

Locations

CN (1)