Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients

Not Applicable

Completed

• Conditions: Postoperative Complications; Postoperative Delirium
• Interventions: Device: Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure; Other: Usual care

• Registration Number: NCT03726073
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

Postoperative delirium is with increased incidence in elderly patients. Previous studies have shown that acupuncture related techniques could induce protection against brain ischemia and improve outcome after cerebral diseases. In this study the effect of transcutaneous electrical acupoint stimulation combined with auricular acupressure on postoperative delirium will be evaluated.

Detailed Description

Postoperative delirium (POD) is an acute neurological disorder that commonly happens between postoperative days 1 and 3 and more common reported in elderly patients. The rate of delirium differs depending on the patients' characteristics, surgery types and setting of health care. The prevalence of delirium range from 18% to 35 % in a general medical service, and up to half of older patients postoperatively. It has been documented that POD is associated with an increase in mortality and morbidity, increased use of hospital resources, and higher cost of health care. The conventional preventive methods for delirium have focused on minimization or elimination of the predisposing and precipitating factors. Yet, few effective therapies are available for treating POD. New treatments are needed to reduce the prevalence and severity of delirium.

Complementary therapies, particularly acupuncture, have gained increasing attention for their possible value in the prevention and treatment of neurological disorders. Both basic and clinical studies have suggested that acupuncture may be beneficial to postoperative delirium. In functional MRI studies of healthy subjects and nervous system dysfunction patients, acupuncture has been shown to stimulate hippocampus, amygdala and insula, areas of the brain associated with memory, cognition and emotion.

In the clinical, TEAS has been reported to be effective in alleviating delirium in elderly patients with silent lacunar infarction. Evidence also showed that auricular acupunctures are efficacious for preventing postoperative agitation in geriatric patients

Given evidences of the possible efficacy of TEAS and auricular acupressure, we aim to do a 2-arm, randomized, controlled, single-blinded, pragmatic trial to investigate whether transcutaneous electrical acupoint stimulation combined with auricular acupressure is more effective in reducing postoperative delirium in elderly patients than usual care.

Study Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2019-04-17
• Primary Completion: 2020-03-10
• Study Completion: 2020-04-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patients scheduled for elective abdominal surgery under general anesthesia
• American Society of Anesthesiologists (ASA) physical status class≤Ⅲ;
• Mini mental state examination (MMSE) score>20;

Exclusion Criteria

• Implantation of a cardiac pacemaker, cardioverter, defibrillator or internal hearing aids;
• Documented alcohol or substance abuse within 3 months before surgery;
• Dermatological conditions or frail skin;
• Dysesthesia or infection over the acupoint stimulation skin area;
• Limb abnormalities;
• Allergy to ECG pads;
• Use of psychoactive medications;
• Severe visual or auditory impairment;
• Preoperative history of schizophrenia, epilepsy, parkinsonism, depression, or myasthenia gravis;
• Brain injury or neurosurgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure	Electrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days
Non-intervention group	Usual care	Usual care

Primary Outcome Measures

Name	Time	Method
Incidence of delirium	From the end of surgery to 7 days after surgery	In postoperative 7 days or during patients stay in hospital if discharged within 7 days
The severity of delirium	From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days	Assessed by memorial delirium assessment scale (MDAS)

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24h, 48h, 72h after surgery	Postoperative pain both at rest and with movement using Numeric Rating Scale (NRS)
Tumor necrosis factor-α level	Before surgery and at the end of the surgery	Serum
S100B level	Before surgery and at the end of the surgery	Serum
Postoperative sleep qualiy	4 days after surgery	Sleep quality within postoperative 4 days using Pittsburgh sleep quality index (PSQI)
Length of stay in hospital after sugery	From the day of suregry to discharge from surgery	Days
Matrix metalloproteinase 9 level	Before surgery and at the end of the surgery	Serum
Neuron-specific enolase level	Before surgery and at the end of the surgery	Serum
Brain-derived neurotrophic factor level	Before surgery and at the end of the surgery	Serum
Aquaporin-4 level	Before surgery and at the end of the surgery	Serum
Interleukin-10 level	Before surgery and at the end of the surgery	Serum
Interleukin- 6 level	Before surgery and at the end of the surgery	Serum
Tau protain level	Before surgery and at the end of the surgery	Serum
β-Amyloid1-42 level	Before surgery and at the end of the surgery	Serum

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China