Clinical trial NCT03726073: Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Postoperative Delirium
Keywords: Delirium
Elderly patients
Transcutaneous acupoint electrical acupoint stimulation
Auricular acupressure
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of delirium
timeFrame: From the end of surgery to 7 days after surgery
measure: The severity of delirium
timeFrame: From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24h, 48h, 72h after surgery
measure: S100B level
timeFrame: Before surgery and at the end of the surgery
measure: Neuron-specific enolase level
timeFrame: Before surgery and at the end of the surgery
measure: Brain-derived neurotrophic factor level
timeFrame: Before surgery and at the end of the surgery
measure: Tumor necrosis factor-α level
timeFrame: Before surgery and at the end of the surgery
measure: Interleukin- 6 level
timeFrame: Before surgery and at the end of the surgery
measure: Aquaporin-4 level
timeFrame: Before surgery and at the end of the surgery
measure: Postoperative sleep qualiy
timeFrame: 4 days after surgery
measure: Length of stay in hospital after sugery
timeFrame: From the day of suregry to discharge from surgery
measure: Interleukin-10 level
timeFrame: Before surgery and at the end of the surgery
measure: Matrix metalloproteinase 9 level
timeFrame: Before surgery and at the end of the surgery
measure: Tau protain level
timeFrame: Before surgery and at the end of the surgery
measure: β-Amyloid1-42 level
timeFrame: Before surgery and at the end of the surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Zhihong Lu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.