The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- The incidence of postoperative delirium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Severe liver and kidney dysfunction
- •here were mental and nervous system diseases before operation
- •Have a history of alcoholism, long-term use of sedative or analgesic
- •A history of a delirium and other reasons are reluctant to cooperate
- •Massive blood loss and blood transfusion during operation, prolonged operation time
Arms & Interventions
40Hz stimulation group
At the start of anesthesia, the subject received 40Hz transcranial stimulation for 1h.
Intervention: 40Hz stimulation (Device)
Control group
At the start of anesthesia, the subject did not receive any additional treatment.
Outcomes
Primary Outcomes
The incidence of postoperative delirium
Time Frame: 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 Outcomes
- Blood Markers(Preoperative and postoperative 1 d and 2 d)
- The incidence of postoperative nausea and vomiting(Day 1, Day 2, Day 3 after surgery)
- Sleep quality(Day 1, day 2, day 3 after surgery)
- The incidence of pain(Day 1, day 2, day 3 after surgery)