The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients.

The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients

Delirium is an acute confusional state, it is a sign of acute encephalopathy, also known as acute brain failure, acute brain dysfunction or mental state changes.Postoperative delirium can cause post-traumatic stress disorder, affects patients' quality of life, extend the length of hospital stay, increased hospitalization cost, and is closely relative to short-term and long-term mortality after surgery. 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 hip and knee replacement.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 110
• 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:

1.65-85 years old, gender not limited 2.General anesthesia unilateral total hip replacement surgery or unilateral total knee replacement 3.ASA classification I-III 4.No drugs for mental and central nervous system diseases were used before surgery 5.Preoperative MMSE score illiterate > 17 points, primary > 20 points, junior high school and above > 24 points 6.Obtaining informed consent

Exclusion Criteria:

1. Severe liver and kidney dysfunction
2. here were mental and nervous system diseases before operation
3. Have a history of alcoholism, long-term use of sedative or analgesic
4. A history of a delirium and other reasons are reluctant to cooperate
5. Massive blood loss and blood transfusion during operation, prolonged operation time

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
Experimental: 40Hz stimulation group; At the start of anesthesia, the subject received 40Hz transcranial stimulation for 1h.	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.
No Intervention: Control group; At the start of anesthesia, the subject did not receive any additional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative delirium	Postoperative delirium was assessed by CAM scale.The diagnosis of delirium mainly depends on four characteristics: 1 acute fluctuating course; 2 attention disorder; 3 thinking disorder; 4 change of consciousness level. At the same time, 1 and 2, and 3 or 4 can be used to diagnose delirium.	Day 1, Day 2, Day 3 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Markers	Serum Tau proteomic analysis and CRP, IL-6, and B cell levels were recorded	Preoperative and postoperative 1 d and 2 d
The incidence of postoperative nausea and vomiting	Follow up patients for nausea and vomiting	Day 1, Day 2, Day 3 after surgery
Sleep quality	Sleep quality was assessed using a sleep quality scale(QS),(0: no effect on sleep 1: sleep in and out of sleep at night 2: sleep in and out of sleep unable to fall asleep 3: light sleep but unable to fall asleep 4: unable to fall asleep at all)	Day 1, day 2, day 3 after surgery
The incidence of pain	NRS is a dotted ruler from 0 to 10. 0 means no pain, and 10 means unbearable pain. The patient chooses a number from above to describe the pain.	Day 1, day 2, day 3 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 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

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

Drug and device information, study documents

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