Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients (AICE)
Primary Purpose
Postoperative Complications, Postoperative Delirium
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure
Usual care
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring Delirium, Elderly patients, Transcutaneous acupoint electrical acupoint stimulation, Auricular acupressure
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.
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention group
Non-intervention group
Arm Description
Electrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days
Usual care
Outcomes
Primary Outcome Measures
Incidence of delirium
In postoperative 7 days or during patients stay in hospital if discharged within 7 days
The severity of delirium
Assessed by memorial delirium assessment scale (MDAS)
Secondary Outcome Measures
Postoperative pain
Postoperative pain both at rest and with movement using Numeric Rating Scale (NRS)
S100B level
Serum
Neuron-specific enolase level
Serum
Brain-derived neurotrophic factor level
Serum
Tumor necrosis factor-α level
Serum
Interleukin- 6 level
Serum
Aquaporin-4 level
Serum
Postoperative sleep qualiy
Sleep quality within postoperative 4 days using Pittsburgh sleep quality index (PSQI)
Length of stay in hospital after sugery
Days
Interleukin-10 level
Serum
Matrix metalloproteinase 9 level
Serum
Tau protain level
Serum
β-Amyloid1-42 level
Serum
Full Information
NCT ID
NCT03726073
First Posted
October 28, 2018
Last Updated
May 25, 2022
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT03726073
Brief Title
Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Delirium
Keywords
Delirium, Elderly patients, Transcutaneous acupoint electrical acupoint stimulation, Auricular acupressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
transcutaneous electrical acupoint stimulation and auricular acupressure is given by an investigator who is not involved in anesthesia and outcome assessment
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Electrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days
Arm Title
Non-intervention group
Arm Type
Sham Comparator
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure
Intervention Description
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 Type
Other
Intervention Name(s)
Usual care
Intervention Description
Patients in this group only receive usual care developed by the study hospital
Primary Outcome Measure Information:
Title
Incidence of delirium
Description
In postoperative 7 days or during patients stay in hospital if discharged within 7 days
Time Frame
From the end of surgery to 7 days after surgery
Title
The severity of delirium
Description
Assessed by memorial delirium assessment scale (MDAS)
Time Frame
From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain both at rest and with movement using Numeric Rating Scale (NRS)
Time Frame
24h, 48h, 72h after surgery
Title
S100B level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Neuron-specific enolase level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Brain-derived neurotrophic factor level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Tumor necrosis factor-α level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Interleukin- 6 level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Aquaporin-4 level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Postoperative sleep qualiy
Description
Sleep quality within postoperative 4 days using Pittsburgh sleep quality index (PSQI)
Time Frame
4 days after surgery
Title
Length of stay in hospital after sugery
Description
Days
Time Frame
From the day of suregry to discharge from surgery
Title
Interleukin-10 level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Matrix metalloproteinase 9 level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
Tau protain level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
Title
β-Amyloid1-42 level
Description
Serum
Time Frame
Before surgery and at the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Lu
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30425466
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.
Results Reference
background
PubMed Identifier
19875431
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.
Results Reference
background
PubMed Identifier
26676760
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.
Results Reference
background
PubMed Identifier
28231740
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.
Results Reference
background
PubMed Identifier
35783617
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.
Results Reference
derived
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Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients
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