Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients (AICE)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Delirium
• Intervention / Treatment: Device: Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years to 96 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Electrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days	Device: Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure; 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.
Sham Comparator: Non-intervention group; Usual care	Other: Usual care; Patients in this group only receive usual care developed by the study hospital

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Zhihong Lu, Xijing Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Elderly patients; Delirium; Transcutaneous acupoint electrical acupoint stimulation; Auricular acupressure
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Postoperative Complications
• Other Study ID Numbers: XJH-A-20181001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data of the study will be available for sharing after publishing, including data of the outcomes
• IPD Sharing Time Frame: The data of the study will be available for sharing after publishing on peer-reviewed journals, and will be available for 5 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No