Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor：a Protocol of Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Mini-Mental State Examination(MMSE)
研究概览
简要总结
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.
详细描述
Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •⑧ Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 min during the operation.
- •⑨ Patients admitted to ICU after operation.
- •⑩ Patients who quit or died due to noncooperation or sudden situation.
- •⑪ Patients who already participate in other clinical studies which may influence this study.
- •⑫ Patients who underwent emergency surgery.
- •⑬ Patients who had a history of acupuncture treatment.
研究组 & 干预措施
preoperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before anesthesia.
干预措施: Transcutaneous acupoint electrical stimulation (Other)
Intraoperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 30 min before anesthesia to the end of surgery
干预措施: Transcutaneous acupoint electrical stimulation (Other)
Postoperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, once a day, 30 minutes each time for 7 consecutive days after operation
干预措施: Transcutaneous acupoint electrical stimulation (Other)
Pre-and post-operative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 1 day before operation to 7 days after operation, once a day, 30 minutes each time.
干预措施: Transcutaneous acupoint electrical stimulation (Other)
Perioperative TEAS group
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before the induction of anesthesia to the end of the surgery, 1 day before operation, and on the 1st, 2nd and 3rd days after surgery, 30 min once a day.
干预措施: Transcutaneous acupoint electrical stimulation (Other)
Sham TEAS group
the electrodes were placed at the same time as the perioperative TEAS group, but the electronic stimulation was not applied and they were told that the TEAS treatment have no feeling
干预措施: Transcutaneous acupoint electrical stimulation (Other)
Control group
receive standardised perioperative management such as preoperative health education, optimize anaesthesia scheme, intraoperative heat preservation, and reduce surgical trauma.
结局指标
主要结局
Mini-Mental State Examination(MMSE)
时间窗: From preoperative to 3 days after operation
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.
Auditory Verbal Learning Test-HuaShan version(AVLT-H)
时间窗: From preoperative to 3 days after operation
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.
Digital Symbol Coding(DSC)
时间窗: From preoperative to 3 days after operation
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.
Verbal Fluency Test(VFT)
时间窗: From preoperative to 3 days after operation
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.
Clock Drawing Task(CDT)
时间窗: From preoperative to 3 days after operation
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.
次要结局
- Postoperative exhaust time(The second day after operation)
- Numerical pain score(NRS)(on the third day after operation)
- Telephone Interview for Cognitive Status-Modified(TICS-m)(1, 3, 6 months after operation.)
- Postoperative eating time(The second day after operation)
- Score of Branden pressure ulcer risk assessment scale(Branden)(The seventh day after operation)
- Postoperative defecation time(The second day after operation)
- The time of get out of bed for the first time after operation(The second day after operation)
- 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)
- Score of Barthel index (BI)(The seventh day after 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)
研究者
Lijuan Xi
Nurse
Yangzhou University