Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram

Study Overview
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Brief Summary
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Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.

Official Title
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Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium and EEG Characteristic Parameters in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia

Conditions
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Anesthesia, Postoperative Delirium, Electroencephalogram

Intervention / Treatment
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* Other: transcutaneous electrical acupoint stimulation
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 65 years or older American Society of Anesthesiologists (ASA) classification≤ Grade III Patients scheduled for elective abdominal surgery under general anesthesia Informed consent Exclusion Criteria: Patients with severe central nervous system injury or severe cerebrovascular disease Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication Patients with severe hepatic and renal insufficiency Patients with severe respiratory diseases Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous electrical stimulation<br>At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and Shenmen point and connected to the percutaneous acupoint electrical stimulation device (Hwato , Suzhou Medical Equipment Factory). Electrical stimulation is given. | Other: transcutaneous electrical acupoint stimulation<br>* Electrodes will be attached on the surface of acupoints and electrical stimulation will be given<br>* Other names: TEAS;|
| Other: Control<br>At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation | Other: Control<br>* Electrodes will be attached on the surface of acupoints but no stimulation will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium by 7 days after surgery | Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method | from end of surgery to 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal electroencephalogram (EEG) alpha band power reduction |  | From anesthesia induction to the end of surgery | 
| Maximal decrease of regional cerebral oxygen saturation |  | From anesthesia induction to the end of surgery | 
| EEG explosive suppression time | EEG burst suppression is defined as a burst-suppression ratio (BSR) ≥ 10%, more than 1 minute | From anesthesia induction to the end of surgery | 
| Incidence of major neurological complications | Coma, stroke, altered state of consciousness | From end of surgery to discharge from hospital, at an average of 7 days | 
| The Athens Insomnia Scale and Epworth somnolence Scale score by 1 day after surgery |  | From end of surgery to 1 day after surgery | 
| The Athens Insomnia Scale and Epworth somnolence Scale score by 3 days after surgery |  | From end of surgery to 3 days after surgery | 
| The Hospital Anxiety and Depression Scales by 1 day after surgery |  | From end of surgery to 1 day after surgery | 
| The Hospital Anxiety and Depression Scales by 3 days after surgery |  | From end of surgery to 3 days after surgery | 
| The Quality of Recovery-15 Score by 1 day after surgery |  | From end of surgery to 1 day after surgery | 
| The Quality of Recovery-15 Score by 3 days after surgery |  | From end of surgery to 1 day after surgery | 
| Incidence of delirium by 1 day after surgery |  | From end of surgery to 1 day after surgery | 
| Incidence of delirium by 3 days after surgery |  | From end of surgery to 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous electrical acupoint stimulation, Postoperative delirium, Electroencephalogram