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.
Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
238
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.
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From preoperative to 3 days after operation
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.
Time frame: Baseline and on the 3rd day after the operation
S100 calcium proteinβ(S100β)
Evaluate patients' postoperative inflammatory status. S100β 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.
Time frame: Baseline and on the 3rd day after the operation
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.
Time frame: Baseline and on the 3rd day after the operation
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.
Time frame: Baseline and on the 3rd day after the operation
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.
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Time frame: on the third day after operation
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.
Time frame: The seventh day after operation
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.
Time frame: The seventh day after operation
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.
Time frame: 1, 3, 6 months after operation.
Postoperative exhaust time
Record the first anal exhaust time after operation
Time frame: The second day after operation
Postoperative defecation time
Record the first defecation time after operation
Time frame: The second day after operation
Postoperative eating time
Record the first eating time after operation
Time frame: The second day after operation
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
Time frame: The second day after operation