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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSubei People's Hospital of Jiangsu Province

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous acupoint electrical stimulation

    Other intervention

    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.

Treatment groups

238 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: preoperative TEAS groupExperimental treatment 1 intervention
Group B: Intraoperative TEAS groupExperimental treatment 1 intervention
Group C: Postoperative TEAS groupExperimental treatment 1 intervention
Group D: Pre-and post-operative TEAS groupExperimental treatment 1 intervention
Group E: Perioperative TEAS groupExperimental treatment 1 intervention
Group F: Sham TEAS groupSham comparator 1 intervention
Group G: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Subei People's Hospital of Jiangsu Province

Lead sponsor

Yangzhou University

Sponsor institution

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