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This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.
Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAS group | Experimental | Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure. |
|
| Electroacupuncture group | Placebo Comparator | Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure. |
|
| sham TEAS group | Sham Comparator | Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Acupoint Stimulation | Device | The intervention will be administered by electrical acupoint machine, the brand is Great Wall. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The postoperative recovery | Record the postoperative recovery after surgery through quality of recovery-40 questionnaire. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The adverse event | Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al. | 7 days |
| The level of stress response | Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Age in years | Once patients enrolled, the age (years) need to be recorded ahead of operation. | 1 day |
| ASA classification status | Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhang weiliang, MD | Contact | 086-0531-68617021 | 6114 | hezhangweiliang@163.com |
| Su Fan, MD | Contact | 086-0531-68617023 | 6114 | boatsail@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Su Fan, MD | Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of shandong university of traditional chinese medicine | Ji'nan | Shandong | 250011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20084351 | Result | Coburn M, Fahlenkamp A, Zoremba N, Schaelte G. Postoperative cognitive dysfunction: Incidence and prophylaxis. Anaesthesist. 2010 Feb;59(2):177-84; quiz 185. doi: 10.1007/s00101-009-1657-2. | |
| 25048507 | Result | Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430. |
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IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
Data will be available within 6 months of study completion, forever.
Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2018 | Mar 28, 2018 |
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The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.
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The intervention administered randomly to the participants. The participants, care providers, investigator, outcomes assessor done their job, separately. The blind will be controlled by a assigned investigator.
| Electroacupuncture | Device | The intervention will be administered by electrical acupoint machine, the brand is Great Wall. |
|
| sham Transcutaneous Electrical Acupoint Stimulation | Device | The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized. |
|
| up to 7 days |
| Postoperative complications | Record the incidence of any postoperative complications during 7 days | 7 days |
| The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10 | Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml. | up to 7 days |
| The level of inflammatory response by C-reactive protein | Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L. | up to 7 days |
| 1 day |
| Gender | Once patients enrolled, the gender need to be recorded ahead of operation. | 1 day |
| Weight in kilograms | Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation. | 1 day |
| Height in meters | Once patients enrolled, the height (meters) need to be recorded ahead of operation. | 1 day |
| BMI in kg/m^2 | Once patients enrolled, the BMI (weight and height will be combined to report BMI in kg/m^2) will be reported base on weight and height ahead of operation. | 1 day |
| 20669525 | Result | Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Rockville (MD): Office of the Surgeon General (US); 2008. Available from http://www.ncbi.nlm.nih.gov/books/NBK44178/ |
| 24693389 | Result | Montazeri AS, Hamidzadeh A, Raei M, Mohammadiun M, Montazeri AS, Mirshahi R, Rohani H. Evaluation of Oral Ginger Efficacy against Postoperative Nausea and Vomiting: A Randomized, Double - Blinded Clinical Trial. Iran Red Crescent Med J. 2013 Dec;15(12):e12268. doi: 10.5812/ircmj.12268. Epub 2013 Dec 5. |
| 25375388 | Result | Sorrell JM. Postoperative cognitive dysfunction in older adults: a call for nursing involvement. J Psychosoc Nurs Ment Health Serv. 2014 Nov;52(11):17-20. doi: 10.3928/02793695-20141021-03. |
| 25355258 | Result | Ge Y, Ma Z, Shi H, Zhao Y, Gu X, Wei H. [Incidence and risk factors of postoperative cognitive dysfunction in patients underwent coronary artery bypass grafting surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2014 Oct;39(10):1049-55. doi: 10.11817/j.issn.1672-7347.2014.10.011. Chinese. |
| 15344424 | Result | Tsay SL, Cho YC, Chen ML. Acupressure and Transcutaneous Electrical Acupoint Stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med. 2004;32(3):407-16. doi: 10.1142/S0192415X04002065. |
| 15992223 | Result | Kabalak AA, Akcay M, Akcay F, Gogus N. Transcutaneous electrical acupoint stimulation versus ondansetron in the prevention of postoperative vomiting following pediatric tonsillectomy. J Altern Complement Med. 2005 Jun;11(3):407-13. doi: 10.1089/acm.2005.11.407. |
| 26170873 | Result | Yao Y, Zhao Q, Gong C, Wu Y, Chen Y, Qiu L, Wu X, Chen Y. Transcutaneous Electrical Acupoint Stimulation Improves the Postoperative Quality of Recovery and Analgesia after Gynecological Laparoscopic Surgery: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:324360. doi: 10.1155/2015/324360. Epub 2015 Jun 11. |
| 18219451 | Result | Zheng LH, Sun H, Wang GN, Liang J, Wu HX. Effect of transcutaneous electrical acupoint stimulation on nausea and vomiting induced by patient controlled intravenous analgesia with tramadol. Chin J Integr Med. 2008 Mar;14(1):61-4. doi: 10.1007/s11655-007-9006-2. |
| ICF_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2018 | Mar 28, 2018 | Prot_SAP_003.pdf |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D020250 | Postoperative Nausea and Vomiting |
| D000071257 | Emergence Delirium |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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