Clinical trial NCT05482477: Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor
Official title: Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor：a Protocol of Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Subei People's Hospital of Jiangsu Province
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 238
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mini-Mental State Examination(MMSE)
timeFrame: From preoperative to 3 days after operation
measure: Auditory Verbal Learning Test-HuaShan version(AVLT-H)
timeFrame: From preoperative to 3 days after operation
measure: Digital Symbol Coding(DSC)
timeFrame: From preoperative to 3 days after operation
measure: Verbal Fluency Test(VFT)
timeFrame: From preoperative to 3 days after operation
measure: Clock Drawing Task(CDT)
timeFrame: From preoperative to 3 days after operation
Secondary outcomes:
measure: Interleukin-6(IL-6)
timeFrame: Baseline and on the 3rd day after the operation
measure: S100 calcium proteinβ(S100β)
timeFrame: Baseline and on the 3rd day after the operation
measure: insulin-like growth factor-1( IGF-1 )
timeFrame: Baseline and on the 3rd day after the operation
measure: C-reactive protein(CRP)
timeFrame: Baseline and on the 3rd day after the operation
measure: Numerical pain score(NRS)
timeFrame: on the third day after operation
measure: Score of Branden pressure ulcer risk assessment scale(Branden)
timeFrame: The seventh day after operation
measure: Score of Barthel index (BI)
timeFrame: The seventh day after operation
measure: Telephone Interview for Cognitive Status-Modified(TICS-m)
timeFrame: 1, 3, 6 months after operation.
measure: Postoperative exhaust time
timeFrame: The second day after operation
measure: Postoperative defecation time
timeFrame: The second day after operation
measure: Postoperative eating time
timeFrame: The second day after operation
measure: The time of get out of bed for the first time after operation
timeFrame: The second day after operation
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People&#39;s Hospital
state: Jiangsu
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.