Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor

Официальное название

Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor：a Protocol of Randomised Controlled Trial

Обзор

Postoperative cognitive dysfunction(POCD). is a central nervous system complication in cancer patients with a 8.9-46.1% incidence. It is mainly manifested as impaired memory, descending information handling ability and decline or damage of attention, perception, abstract thinking, executive, language, and body movement. However, it is difficult to identify and it can last for months or years or even become a dementia state, which can severely affect patients' postoperative recovery, prolong the hospitalization time, reduce the quality of life, increase the mortality and the consumption of family and social medical resources, and intensifies the national economic and social burden. 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.

Подробное описание

Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.

Вмешательства

• Другое 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 anesth

Первичные конечные точки

• Mini-Mental State Examination(MMSE) [Срок оценки: From preoperative to 3 days after operation]
• Auditory Verbal Learning Test-HuaShan version(AVLT-H) [Срок оценки: From preoperative to 3 days after operation]
• Digital Symbol Coding(DSC) [Срок оценки: From preoperative to 3 days after operation]
• Verbal Fluency Test(VFT) [Срок оценки: From preoperative to 3 days after operation]
• Clock Drawing Task(CDT) [Срок оценки: From preoperative to 3 days after operation]

Вторичные конечные точки (12)

• Interleukin-6(IL-6) [Срок оценки: Baseline and on the 3rd day after the operation]
• S100 calcium proteinβ(S100β) [Срок оценки: Baseline and on the 3rd day after the operation]
• insulin-like growth factor-1( IGF-1 ) [Срок оценки: Baseline and on the 3rd day after the operation]
• C-reactive protein(CRP) [Срок оценки: Baseline and on the 3rd day after the operation]
• Numerical pain score(NRS) [Срок оценки: on the third day after operation]
• Score of Branden pressure ulcer risk assessment scale(Branden) [Срок оценки: The seventh day after operation]
• Score of Barthel index (BI) [Срок оценки: The seventh day after operation]
• Telephone Interview for Cognitive Status-Modified(TICS-m) [Срок оценки: 1, 3, 6 months after operation.]
• Postoperative exhaust time [Срок оценки: The second day after operation]
• Postoperative defecation time [Срок оценки: The second day after operation]
• Postoperative eating time [Срок оценки: The second day after operation]
• The time of get out of bed for the first time after operation [Срок оценки: The second day after operation]

Критерии участия

Критерии включения

• Patients aged 60 years or older.

• 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.

Критерии исключения

• Preoperative cognitive dysfunction or history of cognitive dysfunction, dementia, and delirium.

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Northern Jiangsu People&#39;s Hospital — Yangzhou

Публикации

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• 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. PMID 32149824
• 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. PMID 34149572
• 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. PMID 34425851
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• 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. PMID 32387111

Идентификаторы

NCT: NCT05482477 · Lujuan Xi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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