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

N/ARecruitingNCT06522087

Henan Provincial People's Hospital110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

110

Conditions

Postoperative Delirium Anesthesia Elderly

Interventions

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 1, Day 2, Day 3 after surgery

Secondary Outcomes

Blood Markers

Serum Tau proteomic analysis and CRP, IL-6, and B cell levels were recorded

Time frame: Preoperative and postoperative 1 d and 2 d

The incidence of postoperative nausea and vomiting

Follow up patients for nausea and vomiting

Time frame: 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)

Time frame: 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.