Postoperative Complications, Postoperative Delirium
Conditions
Keywords
Delirium, Elderly patients, Transcutaneous acupoint electrical acupoint stimulation, Auricular acupressure
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.
Interventions
DEVICETranscutaneous 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.
OTHERUsual care
Patients in this group only receive usual care developed by the study hospital
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
transcutaneous electrical acupoint stimulation and auricular acupressure is given by an investigator who is not involved in anesthesia and outcome assessment
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium | From the end of surgery to 7 days after surgery | In postoperative 7 days or during patients stay in hospital if discharged within 7 days |
| The severity of delirium | From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days | Assessed by memorial delirium assessment scale (MDAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuron-specific enolase level | Before surgery and at the end of the surgery | Serum |
| Brain-derived neurotrophic factor level | Before surgery and at the end of the surgery | Serum |
| Tumor necrosis factor-α level | Before surgery and at the end of the surgery | Serum |
| Interleukin- 6 level | Before surgery and at the end of the surgery | Serum |
| Aquaporin-4 level | Before surgery and at the end of the surgery | Serum |
| Postoperative pain | 24h, 48h, 72h after surgery | Postoperative pain both at rest and with movement using Numeric Rating Scale (NRS) |
| Length of stay in hospital after sugery | From the day of suregry to discharge from surgery | Days |
| Interleukin-10 level | Before surgery and at the end of the surgery | Serum |
| Matrix metalloproteinase 9 level | Before surgery and at the end of the surgery | Serum |
| Tau protain level | Before surgery and at the end of the surgery | Serum |
| β-Amyloid1-42 level | Before surgery and at the end of the surgery | Serum |
| Postoperative sleep qualiy | 4 days after surgery | Sleep quality within postoperative 4 days using Pittsburgh sleep quality index (PSQI) |
| S100B level | Before surgery and at the end of the surgery | Serum |
Countries
China
Outcome results
None listed