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

Postoperative Cognitive Dysfunction Clinical Trial

— TEAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05482477
• Other study ID #: Lujuan Xi
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Subei People's Hospital of Jiangsu Province
• Contact: Daorong Wang Department Director, Ph.D
• Phone: 18051062590
• Email: daorong666[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 238
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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. ? Preoperative Tilburg frailty scale score is less than 5 points. ? 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.

? Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 min during the operation.

? Patients admitted to ICU after operation.

? Patients who quit or died due to noncooperation or sudden situation.

? Patients who already participate in other clinical studies which may influence this study.

? Patients who underwent emergency surgery.

? Patients who had a history of acupuncture treatment.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Subei People's Hospital of Jiangsu Province

Country where clinical trial is conducted

China, 

References & Publications (9)

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 Agin — View 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. — View 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 — View 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. — View 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. — View 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. Epu — View Citation

Tasbihgou SR, Absalom AR. Postoperative neurocognitive disorders. Korean J Anesthesiol. 2021 Feb;74(1):15-22. doi: 10.4097/kja.20294. Epub 2020 Jul 6. — View 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 Alz — View 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/s13063-021-0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination(MMSE)	Assess the cognitive function of the patient. The MMSE is a 30 points questionnaire used to measure orientation (time and place), memory (immediate and short term), attention, calculation, and language (naming, repetition, listening, reading, and writing) . Higher score means better cognitive function.	From preoperative to 3 days after operation
Primary	Auditory Verbal Learning Test-HuaShan version(AVLT-H)	Assess the cognitive function of the patient. AVLT-H was used to evaluate the memory of the subjects.The subjects learned and recalled 12 words and repeated themself three times. After the nonverbal test interval of about 5min and 20min, the fourth (short delayed recall) and fifth (long delayed recall) repeat will be recorded respectively. The sixth recall was reconfirmation, that is, the data collectors read 24 words, and the subjects answered whether they had learned them. According to the knowledge level and cooperation degree of local elderly subjects, the fourth repeat will be recorded and a correct word will get 1 point.	From preoperative to 3 days after operation
Primary	Digital Symbol Coding(DSC)	Assess the cognitive function of the patient. DSC was used to evaluate the executive function of the subjects. For the test, the subjects need to fill in the numbers corresponding to the symbols within 90s. A correct number will get 1 point, up to 90 points.	From preoperative to 3 days after operation
Primary	Verbal Fluency Test(VFT)	Assess the cognitive function of the patient. VFT was used to evaluate the language ability of the subjects. The subjects should say as many names of animals, fruits and vegetables as possible within 1 minute. A correct object will get 1 point, no point will be given if repeated.	From preoperative to 3 days after operation
Primary	Clock Drawing Task(CDT)	Assess the cognitive function of the patient. CDT was used to evaluate the visual spatial structure ability of the subjects. The subjects need to draw the dial of the clock on paper and write the numbers in the correct position. Scoring method: ? Draw a closed circular outline, 1 point. ?The number display and sequence in the dial are correct, 2 points. ?The position of the hour and minute hand is correct, 1 point. To reduce the learning effect, the test time preoperative and postoperative in this study is drawn at 08:10 and 07:50 respectively.	From preoperative to 3 days after operation
Secondary	Interleukin-6(IL-6)	Evaluate patients' postoperative inflammatory status. IL-6 is a pro-inflammatory cytokine which can mediate inflammatory and immune responses in the CNS.	Baseline and on the 3rd day after the operation
Secondary	S100 calcium proteinß(S100ß)	Evaluate patients' postoperative inflammatory status. S100ß is a biomarker which existed in the cell of peripheral and central nervous system(CNS) and it may participate in the mechanism of cognitive impairment.	Baseline and on the 3rd day after the operation
Secondary	insulin-like growth factor-1( IGF-1 )	Evaluate patients' postoperative inflammatory status. As one of the neurotrophic factors, IGF-1 has been proved to have neuroprotective and neuroproliferative effects and it may delay the degeneration of dopaminergic neurons, protect dopaminergic neurons and promote nerve regeneration through a variety of ways, including inhibiting inflammatory reaction. IGF-1 plays an important role in the survival and differentiation of neurons, and is related to a variety of neurodegenerative diseases. Studies showed that the level of serum IGF-1 in patients with Parkinson's disease(PD) is related to cognitive dysfunction, and serum IGF-1 may be a biomarker of cognitive dysfunction in patients with PD.	Baseline and on the 3rd day after the operation
Secondary	C-reactive protein(CRP)	Evaluate patients' postoperative inflammatory status. CRP is a non-specific biomarker inflammation which has been proved to accelerate the development of neurodegenerative disorders by activating microglia, increasing levels of proinflammatory cytokines, and activating the complement cascade.	Baseline and on the 3rd day after the operation
Secondary	Numerical pain score(NRS)	Evaluate the postoperative recovery of patients. On the scale of the 10 point system, the self rating is based on the degree, which is divided into 1-10 levels. According to the corresponding numbers, the pain can be divided into different degrees, that is, level 0 means no pain, level 1-3 means mild pain, level 4-6 means moderate pain, and level 7-10 means severe pain.	on the third day after operation
Secondary	Score of Branden pressure ulcer risk assessment scale(Branden)	Branden is divided into six dimensions: perception, humidity, activity mode, activity ability, nutrition, friction and shear force. The friction and shear force are rated at Level 3, and the rest are rated at level 4, with a score range of 6-23 points. The higher the score, the smaller the risk of pressure ulcer occurrence, with 15-18 points for mild risk, 13-14 points for moderate risk, 10-12 points for high risk, and = 9 points for serious risk.	The seventh day after operation
Secondary	Score of Barthel index (BI)	BI is a tool widely used in clinic to evaluate patients'activities of daily living(ADL). It includes 10 items, including diet, bed and wheelchair transfer, personal hygiene, toileting, bathing, walking, going up and down stairs, dressing, defecation control and urination control, with a total score of 100 points. If the score is in the range of 0 ~ 40 points, it belongs to severe ADL deficiency; if it is in the range of 41 ~ 60 points, it belongs to moderate ADL deficiency; if it is in the range of 61 ~ 100 points, it belongs to mild ADL deficiency. The BI scale can be evaluated by asking patients or their families, which is simple, fast and highly reliability.	The seventh day after operation
Secondary	Telephone Interview for Cognitive Status-Modified(TICS-m)	Assess the cognitive function of the patient. TICS-m is modified from the earliest version of TICS which is modeled on MMSE. Gallo and Breitiner revised the original version, adding tests such as delayed memory of words and five times of phone tapping, and expanded it to 21 items, with a total score of 50 points. It can be divided into three parts: memory (20 points), orientation (13 points), language and attention (17 points). The higher the score, the better the condition of the project. <28 points is defined as dementia, 28~32 points is defined as mild cognitive impairment(MCI). More over the TICS-m has been proved to have good reliability and validity in the Chinese population.	1, 3, 6 months after operation.
Secondary	Postoperative exhaust time	Record the first anal exhaust time after operation	The second day after operation
Secondary	Postoperative defecation time	Record the first defecation time after operation	The second day after operation
Secondary	Postoperative eating time	Record the first eating time after operation	The second day after operation
Secondary	The time of get out of bed for the first time after operation	Record the time of get out of bed for the first time after operation	The second day after operation