Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients

NCT03726073 | Completed DMC

• 1 other identifier: XJH-A-20181001
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Postoperative Delirium

Keywords

Delirium; Elderly patients; Transcutaneous acupoint electrical acupoint stimulation; Auricular acupressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Postoperative pain

  24h, 48h, 72h after surgery

• S100B level

  Before surgery and at the end of the surgery

• Neuron-specific enolase level

  Before surgery and at the end of the surgery

• Brain-derived neurotrophic factor level

  Before surgery and at the end of the surgery

• Tumor necrosis factor-α level

  Before surgery and at the end of the surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Non-intervention group

SHAM COMPARATOR

Usual care

Other: Usual care

Interventions

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.

Intervention group

Usual care OTHER

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

Non-intervention group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (5)

• 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.

  PMID: 30425466 BACKGROUND

• 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.

  PMID: 19875431 BACKGROUND

• 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.

  PMID: 26676760 BACKGROUND

• 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.

  PMID: 28231740 BACKGROUND

• 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.

  PMID: 35783617 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhihong Lu

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: transcutaneous electrical acupoint stimulation and auricular acupressure is given by an investigator who is not involved in anesthesia and outcome assessment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 31, 2018
• Study Start: April 17, 2019
• Primary Completion: March 10, 2020
• Study Completion: April 10, 2020
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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

Locations

CN (1)