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 statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 40Hz stimulation

    Device

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: 40Hz stimulation groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

The incidence of postoperative nausea and vomiting

Follow up patients for nausea and vomiting

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

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
4

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.

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

Other outcomes

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