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

Not Applicable

Recruiting

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

• Registration Number: NCT06522087
• Lead Sponsor: Henan Provincial People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-26
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40Hz stimulation group	40Hz stimulation	At the start of anesthesia, the subject received 40Hz transcranial stimulation for 1h.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium	Day 1, Day 2, Day 3 after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Blood Markers	Preoperative and postoperative 1 d and 2 d	Serum Tau proteomic analysis and CRP, IL-6, and B cell levels were recorded
The incidence of postoperative nausea and vomiting	Day 1, Day 2, Day 3 after surgery	Follow up patients for nausea and vomiting
Sleep quality	Day 1, day 2, day 3 after surgery	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)
The incidence of pain	Day 1, day 2, day 3 after surgery	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.

Trial Locations

Locations (1)

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