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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06522087
Enrollment
110
Registered
2024-07-26
Start date
2024-05-01
Completion date
2025-03-15
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Elderly, Postoperative Delirium

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.

Interventions

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.

Sponsors

Henan Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative deliriumDay 1, Day 2, Day 3 after surgeryPostoperative 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

MeasureTime frameDescription
Blood MarkersPreoperative and postoperative 1 d and 2 dSerum Tau proteomic analysis and CRP, IL-6, and B cell levels were recorded
The incidence of postoperative nausea and vomitingDay 1, Day 2, Day 3 after surgeryFollow up patients for nausea and vomiting
Sleep qualityDay 1, day 2, day 3 after surgerySleep 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 painDay 1, day 2, day 3 after surgeryNRS 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.

Countries

China

Contacts

Primary ContactZhang jiaqiang
hnmzxh@163.com037165580728

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026