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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous electrical stimulation | Experimental | 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. |
|
| Control | Other | At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous electrical acupoint stimulation | Other | Electrodes will be attached on the surface of acupoints and electrical stimulation will be given |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| electroencephalogram (EEG) alpha band power | From anesthesia induction to the end of surgery | |
| Maximal decrease of regional cerebral oxygen saturation | From anesthesia induction to the end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of the Air Force Military Medical University | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130079 | Background | Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13. | |
| 30565342 |
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individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification
during 3 months and 5 years following article publication after deidentification
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2023 | Nov 28, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2023 | Nov 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Four or six patients were defined as a block group and the results were sealed in envelopes using computer-generated block randomisation by a researcher not involved in clinical anesthesia. After the patients were enrolled, the study nurse opened the envelope according to the corresponding enrollment number and obtained the group results.
|
| Control | Other | Electrodes will be attached on the surface of acupoints but no stimulation will be given |
|
| Incidence of major complications | myocardial ischemia needing intervention, heart failure, respiratory failure, pneumonia, Coma, stroke, altered state of consciousness | From end of surgery to discharge from hospital, at an average of 7 days |
| The numerical rating scale of sleep quality | The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality | From end of surgery to 1 day after surgery |
| The numerical rating scale of pain | The scale is from 0 to 10. 0 is no pain, 10 is the worst pain | From end of surgery to 1 day after surgery |
| The numerical rating scale of sleep quality | The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality | From end of surgery to 3 days after surgery |
| The numerical rating scale of pain | The scale is from 0 to 10. 0 is no pain, 10 is the worst pain | From end of surgery to 3 days after surgery |
| The Quality of Recovery-15 Score by 3 days after surgery | From end of surgery to 3 days 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 |
| opioid consumption for patient controlled analgesia | the consumption is converted to morphine equivalence | From end of surgery to 1 day after surgery |
| number of attempts for patient controlled analgesia | number of patients pressing the bolus button of the patient controlled analgesia device, indicating that the patient feel pain | From end of surgery to 1 day after surgery |
| total sleep time | From end of surgery to 1 day after surgery |
| Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |