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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

238

participants targeted

Target at P75+ for not_applicable

Timeline

8mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Progress68%

Jan 2025Dec 2026

First Submitted

Initial submission to the registry

July 24, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed

2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected

Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

July 24, 2022

Last Update Submit

September 17, 2024

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (5)

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
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
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
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
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: ① Draw a closed circular outline, 1 point. ②The number display and sequence in the dial are correct, 2 points. ③The 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 Outcomes (12)

Interleukin-6(IL-6)
Baseline and on the 3rd day after the operation
S100 calcium proteinβ(S100β)
Baseline and on the 3rd day after the operation
insulin-like growth factor-1( IGF-1 )
Baseline and on the 3rd day after the operation
C-reactive protein(CRP)
Baseline and on the 3rd day after the operation
Numerical pain score(NRS)
on the third day after operation
+7 more secondary outcomes