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The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions
Existing clinical studies have shown that TEAS has demonstrated value in preventing postoperative delirium (POD). Currently, taVNS is commonly used clinically to improve patients' cognitive dysfunction (POCD), and POD is often considered a precursor to the development of POCD. However, no one has yet used the two in combination, so this study aimed to combine the two to investigate their potential benefits in preventing POD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Prior to induction of anaesthesia, patients in this group received transcutaneous electrical stimulation of acupuncture points for 30 min, followed by standardised anaesthesia. |
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| Group B | Experimental | Prior to induction of anaesthesia, patients in this group received transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation for a total of 30 min, followed by standardised anaesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical acupoint stimulation | Device | Before induction of anaesthesia, electrodes were attached to selected acupoints and energised for 30 min, with the electrical stimulation parameter of dispersed dense wave (2/100 Hz), and the current intensity was based on the maximum current intensity that could be tolerated by the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | Whether delirium occurred after surgery(by 3D-CAM) | The first to third days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 andTNF-α level | the level of IL-6 andTNF-α in the participant's serum(by ELISA) | before operation(Before anesthesia),the end of the operation(Immediately after the sewing is finished) |
| VAS pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lulu Ji | Affiliated Hospital of Nantong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital Nantong University | Nantong | Jiangsu | 226000 | China |
The IPDs collected in the experiment were published only as the results of the paper
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|
| Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation | Device | Before anaesthesia induction, the electrodes were attached to the selected acupoints and energized for 30 min, with the electrical stimulation parameters of dispersed dense wave (2/100Hz), and the current intensity was based on the maximum current intensity that the patient could tolerate. At the same time, the left ear auricular region was stimulated with a fasciculus nerve stimulator, the electrical stimulation parameters were: pulse width of 250 μs, pulse frequency of 20Hz, every 30s on, 30s off, and then 30s on again, the current intensity was based on the maximum current intensity that the patient could tolerate, for 30min. |
|
Assessed with a VAS score scale, the highest is 10 and the lowest is 0, the higher the more severe the pain
| The first to third days after surgery |
| Early activities | The first time to be able to get out of bed and move | Post-operative period until discharge(in about a week) |
| Time to first postoperative anal defecation | Time to first postoperative anal defecation | Post-operative period until discharge(In about a week) |
| Adverse events | Nausea and vomiting, sore throat, itching | The first to third days after surgery |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| 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 |
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