Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor
NCT ID: NCT05482477
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
238 participants
INTERVENTIONAL
2025-01-01
2026-12-30
Brief Summary
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Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Also, studies have shown that TEAS treatment may improve the cognitive function of geriatric patients. Most studies have shown that TEAS treatment 10\~30 minutes before operation or from entering the operating room to the end of operation can reduce the incidence of POCD in elderly patients. Some studies showed that preoperative combined with postoperative or simple postoperative TEAS treatment can significantly improve patients' postoperative cognitive function. Our previous research showed that perioperative TEAS treatment can reduce the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor. Moreover, studies showed that long-term electroacupuncture treatment is easy to cause "tolerance effect', leading to the activation of the negative feedback mechanism of the body, and reduction of the number of receptors, and the weakening of the treatment effect. So, what is the best time period for TEAS to improve POCD and reduce the use of resources? Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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preoperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before anesthesia.
Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Intraoperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 30 min before anesthesia to the end of surgery
Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Postoperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, once a day, 30 minutes each time for 7 consecutive days after operation
Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Pre-and post-operative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 1 day before operation to 7 days after operation, once a day, 30 minutes each time.
Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Perioperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before the induction of anesthesia to the end of the surgery, 1 day before operation, and on the 1st, 2nd and 3rd days after surgery, 30 min once a day.
Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Sham TEAS group
the electrodes were placed at the same time as the perioperative TEAS group, but the electronic stimulation was not applied and they were told that the TEAS treatment have no feeling
Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Control group
receive standardised perioperative management such as preoperative health education, optimize anaesthesia scheme, intraoperative heat preservation, and reduce surgical trauma.
No interventions assigned to this group
Interventions
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Transcutaneous acupoint electrical stimulation
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia in Subei People's Hospital of Jiangsu province.
* Patients willing and able to give informed consent and comply with this study protocol.
* American Society of Anesthesiology (ASA) classification I～III. ⑤ Preoperative Tilburg frailty scale score is less than 5 points. ⑥ Preoperative D-dimer was normal.
Exclusion Criteria
* History of severe depression, schizophrenia, or other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past.
* Patients with severe hearing or visual impairment without assistive tools.
* Patients who have difficulty in communicating.
* Male patients average daily pure alcohol intake ≥ 61 g or female patients average daily pure alcohol intake ≥ 41 g.
* Patients received surgical treatment within 3 months or preoperative hospitalized over 3 months.
* Patients with severe heart, liver, or renal failure.
⑧ Patients with hypoxemia (blood oxygen saturation \< 94%) more than 10 min during the operation.
⑨ Patients admitted to ICU after operation.
⑩ Patients who quit or died due to noncooperation or sudden situation.
⑪ Patients who already participate in other clinical studies which may influence this study.
⑫ Patients who underwent emergency surgery.
⑬ Patients who had a history of acupuncture treatment.
60 Years
ALL
No
Sponsors
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Subei People's Hospital of Jiangsu Province
OTHER
Responsible Party
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Lijuan Xi
Nurse
Locations
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Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu J, Huang K, Zhu B, Zhou B, Ahmad Harb AK, Liu L, Wu X. Neuropsychological Tests in Post-operative Cognitive Dysfunction: Methods and Applications. Front Psychol. 2021 Jun 4;12:684307. doi: 10.3389/fpsyg.2021.684307. eCollection 2021.
Xi L, Fang F, Yuan H, Wang D. Transcutaneous electrical acupoint stimulation for postoperative cognitive dysfunction in geriatric patients with gastrointestinal tumor: a randomized controlled trial. Trials. 2021 Aug 23;22(1):563. doi: 10.1186/s13063-021-05534-9.
Ricci M, Graef S, Blundo C, Miller LA. Using the Rey Auditory Verbal Learning Test (RAVLT) to differentiate alzheimer's dementia and behavioural variant fronto-temporal dementia. Clin Neuropsychol. 2012;26(6):926-41. doi: 10.1080/13854046.2012.704073. Epub 2012 Jul 18.
Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.
Lin X, Chen Y, Zhang P, Chen G, Zhou Y, Yu X. The potential mechanism of postoperative cognitive dysfunction in older people. Exp Gerontol. 2020 Feb;130:110791. doi: 10.1016/j.exger.2019.110791. Epub 2019 Nov 23.
Deiner S, Liu X, Lin HM, Jacoby R, Kim J, Baxter MG, Sieber F, Boockvar K, Sano M. Does Postoperative Cognitive Decline Result in New Disability After Surgery? Ann Surg. 2021 Dec 1;274(6):e1108-e1114. doi: 10.1097/SLA.0000000000003764.
Bertola L, Mota NB, Copelli M, Rivero T, Diniz BS, Romano-Silva MA, Ribeiro S, Malloy-Diniz LF. Graph analysis of verbal fluency test discriminate between patients with Alzheimer's disease, mild cognitive impairment and normal elderly controls. Front Aging Neurosci. 2014 Jul 29;6:185. doi: 10.3389/fnagi.2014.00185. eCollection 2014.
Leissing-Desprez C, Thomas E, Segaux L, Broussier A, Oubaya N, Marie-Nelly N, Laurent M, Cleret de Langavant L, Fromentin I, David JP, Bastuji-Garin S. Understated Cognitive Impairment Assessed with the Clock-Drawing Test in Community-Dwelling Individuals Aged >/=50 Years. J Am Med Dir Assoc. 2020 Nov;21(11):1658-1664. doi: 10.1016/j.jamda.2020.03.016. Epub 2020 May 6.
Yin W, Fang F, Zhang Y, Xi L. Timing of transcutaneous acupoint electrical stimulation for postoperative recovery in geriatric patients with gastrointestinal tumors: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Mar 5;12:1497647. doi: 10.3389/fmed.2025.1497647. eCollection 2025.
Other Identifiers
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Lujuan Xi
Identifier Type: -
Identifier Source: org_study_id
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