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Completed

NCT Number: NCT03726073

Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients

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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure

Device

Bilaterally Hegu (LI4), Neiguan (PC6) and Zusanli (ST36) will be used as the TEAS acupoints. Six acupoints (Shenmen, Point Zero, subcortex, heart, liver, and endocrine) located on ears will be used as the auricular acupressure points.

Usual Care

Other

Patients in this group only receive usual care developed by the study hospital

Primary outcomes

  1. Incidence of delirium

    Time frame: 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

  2. The severity of delirium

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: 24h, 48h, 72h after surgery

    Postoperative pain both at rest and with movement using Numeric Rating Scale (NRS)

  2. S100B level

    Time frame: Before surgery and at the end of the surgery

    Serum

  3. Neuron-specific enolase level

    Time frame: Before surgery and at the end of the surgery

    Serum

  4. Brain-derived neurotrophic factor level

    Time frame: Before surgery and at the end of the surgery

    Serum

  5. Tumor necrosis factor-α level

    Time frame: Before surgery and at the end of the surgery

    Serum

  6. Interleukin- 6 level

    Time frame: Before surgery and at the end of the surgery

    Serum

  7. Aquaporin-4 level

    Time frame: Before surgery and at the end of the surgery

    Serum

  8. Postoperative sleep qualiy

    Time frame: 4 days after surgery

    Sleep quality within postoperative 4 days using Pittsburgh sleep quality index (PSQI)

  9. Length of stay in hospital after sugery

    Time frame: From the day of suregry to discharge from surgery

    Days

  10. Interleukin-10 level

    Time frame: Before surgery and at the end of the surgery

    Serum

  11. Matrix metalloproteinase 9 level

    Time frame: Before surgery and at the end of the surgery

    Serum

  12. Tau protain level

    Time frame: Before surgery and at the end of the surgery

    Serum

  13. β-Amyloid1-42 level

    Time frame: Before surgery and at the end of the surgery

    Serum

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Effect of Transcutaneous Acupoint Electrical Acupoint Stimulation Combined With Auricular Acupressure on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Pragmatic Randomized Clinical Trial

Acronym: AICE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2018
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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