Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients

Postoperative Complications Clinical Trial

— AICE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726073
• Other study ID #: XJH-A-20181001
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: May 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In this study the effect of transcutaneous electrical acupoint stimulation combined with auricular acupressure on postoperative delirium will be evaluated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective abdominal surgery under general anesthesia

• American Society of Anesthesiologists (ASA) physical status class=?;

• 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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Complications
• Postoperative Delirium

Intervention

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.

Other:
• Usual care
Patients in this group only receive usual care developed by the study hospital

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

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