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

NCT06522087 | Recruiting

• 1 other identifier: Henan BJ
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Anesthesia; Elderly

Outcome Measures

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.

  Day 1, Day 2, Day 3 after surgery

Secondary Outcomes (4)

• 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

Study Arms (2)

40Hz stimulation group

EXPERIMENTAL

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

Device: 40Hz stimulation

Control group

NO INTERVENTION

At the start of anesthesia, the subject did not receive any additional treatment.

Interventions

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.

40Hz stimulation group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan People's Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhang jiaqiang

CONTACT

037165580728; hnmzxh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: May 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-07

Locations

CN (1)