Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction in Geriatric Patients With Gastrointestinal Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606888
• Other study ID #: LijuanXi
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Subei People's Hospital of Jiangsu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative cognitive dysfunction (POCD) is one of the common complications of cancer patients after operation with a 8.9%-46.1% incidence, which severely affecting patients' postoperative recovery, increasing the medical cost, affecting the social function of patients, reducing the quality of life and increasing the mortality.

Surgical trauma and perioperative pain can induce systematic inflammatory response and release systematic inflammatory mediators, which can enter the central nervous system (CNS) and lead to CNS inflammatory. In order to prevent the development of POCD among elder patients, the discovery of effective interventions reducing perioperative pain and inflammatory response is important.

Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive alternative to needle-based electro-acupuncture (EA). It combines the acupuncture and transcutaneous electrical nerve stimulation (TENS) by pasting the electrode piece on the acupoint instead of sticking the needles on the skin. TEAS can trigger the release of endogenous neurotransmitters, releasing endogenous analgesic substances, such as endorphins. TEAS also can reduce the intraoperative anesthetic consumption, postoperative pain score, postoperative nausea and vomiting (PONV), and improve the postoperative recovery of patients. Recently, TEAS was found to improve the cognitive function of geriatric patients with silent lacunar infarction. However, the current TEAS mainly focus on intraoperative. The effect of perioperative TEAS on POCD is not clear.

Here, the effect of TEAS on POCD in geriatric adults undergoing radical resection of gastrointestinal tumors under general anesthesia was investigated to determine whether TEAS can decrease perioperative pain or inflammatory response to prevent the occurrence of POCD and to find out the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.

Description:

This study aims to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in elderly patients who were diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia and to determine the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients aged 60 years or older;

2. Patients were diagnosed with gastrointestinal tumor and received radical; resection of gastrointestinal tumors under general anesthesia in Subei people's hospital of Jiangsu province;

3. The patients understood the research content and signed the informed consent form;

4. American Society of Anesthesiology (ASA) score I-III;

5. No frailty before operation;

6. D-dimer was normal before the operation

Exclusion Criteria:

1. Patients with cognitive dysfunction before the operation or patients with previous history of cognitive dysfunction, dementia and delirium;

2. Patients with a history of severe depression, schizophrenia and other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past;

3. Patients with severe hearing or visual impairment due to eye or ear diseases without assistive tools;

4. Patients who are unable to communicate or have difficulty communicating;

5. According to the definition of "China chronic disease and its risk factors monitoring report (2010)" (male average daily pure alcohol intake = 61g, female average daily pure alcohol intake = 41g, alcohol volume (g) = alcohol consumption (ML) × alcohol content% × 0.8);

6. Patients who were hospitalized for three months or more before surgery or who had received surgical treatment within three months;

7. Patients who can't take care of themselves or are physically disabled and unable to carry out nerve function test;

8. Patients with severe heart, liver and renal failure;

9. Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 minutes during operation;

10. Patients admitted to ICU after operation;

11. Patients who quit or died due to noncooperation or sudden situation;

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

13. Patient who underwent emergency surgery;

14. Patient had a history of recent or conventional acupuncture treatment.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Device:
• Transcutaneous electrical acupoint stimulation
According to the traditional Chinese medicine 15,three acupuncture points were selected as the target points: bilateral Neiguan ,Yintang and bilateral Zusanli.. A transcutaneous electrical stimulator was used to provide an altered frequency 2/100 Hz,disperse-dense waves,and adjusted intensity which was less than 10mA.

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 (12)

Borges J, Moreira J, Moreira A, Santos A, Abelha FJ. [Impact of postoperative cognitive decline in quality of life: a prospective study]. Rev Bras Anestesiol. 2017 Jul - Aug;67(4):362-369. doi: 10.1016/j.bjan.2016.07.007. Epub 2017 Apr 12. Portuguese. — View Citation

Correction: Influence of postoperative analgesia on systemic inflammatory response and postoperative cognitive dysfunction after femoral fractures surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Oct;44(10):e2. doi: 10.1136/rapm-2018-000023corr1. — View Citation

Deng LQ, Hou LN, Song FX, Zhu HY, Zhao HY, Chen G, Li JJ. Effect of pre-emptive analgesia by continuous femoral nerve block on early postoperative cognitive function following total knee arthroplasty in elderly patients. Exp Ther Med. 2017 Apr;13(4):1592-1597. doi: 10.3892/etm.2017.4099. Epub 2017 Feb 3. — View Citation

Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514. Review. — View Citation

Gao F, Zhang Q, Li Y, Tai Y, Xin X, Wang X, Wang Q. Transcutaneous electrical acupoint stimulation for prevention of postoperative delirium in geriatric patients with silent lacunar infarction: a preliminary study. Clin Interv Aging. 2018 Oct 24;13:2127-2134. doi: 10.2147/CIA.S183698. eCollection 2018. — View Citation

Huang JM, Lv ZT, Zhang B, Jiang WX, Nie MB. Intravenous parecoxib for early postoperative cognitive dysfunction in elderly patients: evidence from a meta-analysis. Expert Rev Clin Pharmacol. 2020 Apr;13(4):451-460. doi: 10.1080/17512433.2020.1732815. Epub 2020 Feb 28. — View Citation

Kotekar N, Shenkar A, Nagaraj R. Postoperative cognitive dysfunction - current preventive strategies. Clin Interv Aging. 2018 Nov 8;13:2267-2273. doi: 10.2147/CIA.S133896. eCollection 2018. Review. — View Citation

Li Y, Huang D, Su D, Chen J, Yang L. Postoperative cognitive dysfunction after robot-assisted radical cystectomy (RARC) with cerebral oxygen monitoring an observational prospective cohort pilot study. BMC Anesthesiol. 2019 Nov 6;19(1):202. doi: 10.1186/s12871-019-0877-5. — View Citation

Lv ZT, Huang JM, Zhang JM, Zhang JM, Guo JF, Chen AM. Effect of Ulinastatin in the Treatment of Postperative Cognitive Dysfunction: Review of Current Literature. Biomed Res Int. 2016;2016:2571080. doi: 10.1155/2016/2571080. Epub 2016 Aug 14. Review. — View Citation

Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. — View Citation

Yang W, Kong LS, Zhu XX, Wang RX, Liu Y, Chen LR. Effect of dexmedetomidine on postoperative cognitive dysfunction and inflammation in patients after general anaesthesia: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(18):e15383. doi: 10.1097/MD.0000000000015383. — View Citation

Zhang Q, Gao Z, Wang H, Ma L, Guo F, Zhong H, Xiong L, Wang Q. The effect of pre-treatment with transcutaneous electrical acupoint stimulation on the quality of recovery after ambulatory breast surgery: a prospective, randomised controlled trial. Anaesthesia. 2014 Aug;69(8):832-9. doi: 10.1111/anae.12639. Epub 2014 May 28. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination score	Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.	In the morning of the day before operation
Primary	Mini-Mental State Examination score	Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.	Three days after operation
Primary	C reactive protein	Assess the inflammatory reaction of the patient	The day before operation.
Primary	C reactive protein	Assess the inflammatory reaction of the patient	The 1st day after the operation.
Primary	C reactive protein	Assess the inflammatory reaction of the patient	The 3rd day after the operation.
Primary	Interleukin-6	Assess the inflammatory reaction of the patient	The day before operation.
Primary	Interleukin-6	Assess the inflammatory reaction of the patient	The 1st day after the operation.
Primary	Interleukin-6	Assess the inflammatory reaction of the patient	The 3rd day after the operation.
Primary	S100 calcium-binding protein ß	Assess the inflammatory reaction of the patient	The day before operation.
Primary	S100 calcium-binding protein ß	Assess the inflammatory reaction of the patient	The 1st day after the operation.
Primary	S100 calcium-binding protein ß	Assess the inflammatory reaction of the patient	The 3rd day after the operation.
Secondary	Numeric Rating Scale score	Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.	The day before operation
Secondary	Numeric Rating Scale score	Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.	The day of operation
Secondary	Numeric Rating Scale score	Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.	The 1st day after the operation.
Secondary	Numeric Rating Scale score	Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.	The 2rd day after the operation.
Secondary	Numeric Rating Scale score	Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.	The 3nd day after the operation.