AzTrials
AzTrials

Postoperative ComplicationsAICENCT03726073

Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients

A study testing Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure in people with Postoperative Complications and Postoperative Delirium, run by Air Force Military Medical University, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 100 years
What is being tested?
Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
1 siteChina
Study dates
17 Apr 2019to 10 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 10Show fewer
  • Use of psychoactive medications;
  • Severe visual or auditory impairment;
  • Preoperative history of schizophrenia, epilepsy, parkinsonism, depression, or myasthenia gravis;
  • Brain injury or neurosurgery.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official 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

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.

Read the 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.

Being tested
Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure, Usual care
Keywords
Delirium, Elderly patients, Transcutaneous acupoint electrical acupoint stimulation, Auricular acupressure
Medical subject headings
Postoperative Complications, Emergence Delirium, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressureDevice

    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 careOther

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

Study groups in NCT03726073
Study groupRoleWhat they receive
Intervention groupExperimentalElectrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days
Receives: Device: Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure
Non-intervention groupSham comparatorUsual care
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of delirium

    In postoperative 7 days or during patients stay in hospital if discharged within 7 days

    Measured: From the end of surgery to 7 days after surgery

  2. The severity of delirium

    Assessed by memorial delirium assessment scale (MDAS)

    Measured: From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days

Secondary outcomes (13)

  1. Postoperative pain

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

    Measured: 24h, 48h, 72h after surgery

  2. S100B level

    Serum

    Measured: Before surgery and at the end of the surgery

  3. Neuron-specific enolase level

    Serum

    Measured: Before surgery and at the end of the surgery

  4. Brain-derived neurotrophic factor level

    Serum

    Measured: Before surgery and at the end of the surgery

  5. Tumor necrosis factor-α level

    Serum

    Measured: Before surgery and at the end of the surgery

  6. Interleukin- 6 level

    Serum

    Measured: Before surgery and at the end of the surgery

  7. Aquaporin-4 level

    Serum

    Measured: Before surgery and at the end of the surgery

  8. Postoperative sleep qualiy

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

    Measured: 4 days after surgery

  9. Length of stay in hospital after sugery

    Days

    Measured: From the day of suregry to discharge from surgery

  10. Interleukin-10 level

    Serum

    Measured: Before surgery and at the end of the surgery

  11. Matrix metalloproteinase 9 level

    Serum

    Measured: Before surgery and at the end of the surgery

  12. Tau protain level

    Serum

    Measured: Before surgery and at the end of the surgery

  13. β-Amyloid1-42 level

    Serum

    Measured: Before surgery and at the end of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start17 Apr 2019
  3. Primary completion10 Mar 2020
  4. Study completion10 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726073
Sponsor's protocol ID
XJH-A-20181001
Acronym
AICE
Status last verified
May 2022
First submitted
28 Oct 2018
Last updated
26 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data of the study will be available for sharing after publishing, including data of the outcomes

Publications

  • Gao F, Zhang Q, Li Y, Tai Y, Xin X, Wang X, Wang Q. Transcutaneous electrical acupoint stimulation for prevention of postoperative delirium in geriatric patients with silent lacunar infarction: a preliminary study. Clin Interv Aging. 2018 Oct 24;13:2127-2134. doi: 10.2147/CIA.S183698. eCollection 2018.

    PubMed 30425466

  • Arai YC, Ito A, Hibino S, Niwa S, Ueda W. Auricular Acupunctures are Effective for the Prevention of Postoperative Agitation in Old Patients. Evid Based Complement Alternat Med. 2010 Sep;7(3):383-6. doi: 10.1093/ecam/nep172. Epub 2009 Oct 29.

    PubMed 19875431

  • Scholz AF, Oldroyd C, McCarthy K, Quinn TJ, Hewitt J. Systematic review and meta-analysis of risk factors for postoperative delirium among older patients undergoing gastrointestinal surgery. Br J Surg. 2016 Jan;103(2):e21-8. doi: 10.1002/bjs.10062. Epub 2015 Dec 16.

    PubMed 26676760

  • Matsumoto-Miyazaki J, Ushikoshi H, Miyata S, Miyazaki N, Nawa T, Okada H, Ojio S, Ogura S, Minatoguchi S. Acupuncture and Traditional Herbal Medicine Therapy Prevent Deliriumin Patients with Cardiovascular Disease in Intensive Care Units. Am J Chin Med. 2017;45(2):255-268. doi: 10.1142/S0192415X17500161. Epub 2017 Feb 23.

    PubMed 28231740

  • Fan Q, Lei C, Wang Y, Yu N, Wang L, Fu J, Dong H, Lu Z, Xiong L. Transcutaneous Electrical Acupoint Stimulation Combined With Auricular Acupressure Reduces Postoperative Delirium Among Elderly Patients Following Major Abdominal Surgery: A Randomized Clinical Trial. Front Med (Lausanne). 2022 Jun 15;9:855296. doi: 10.3389/fmed.2022.855296. eCollection 2022.

    PubMed 35783617

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure in people with Postoperative Complications and Postoperative Delirium, run by Air Force Military Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of delirium (time frame: From the end of surgery to 7 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03726073, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in