Electrical Acupoint Stimulation for Postoperative Recovery

Postoperative Complications Clinical Trial

— EAS  

Official title:

Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03249701
• Other study ID #: SZH-A-20170501-R2
• Status: Not yet recruiting
• Phase: N/A
• First received: August 3, 2017
• Last updated: March 30, 2018
• Start date: May 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2018
• Source: Shandong University of Traditional Chinese Medicine
• Contact: zhang weiliang, MD
• Phone: 086-0531-68617021
• Email: hezhangweiliang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 30, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Agree to sign the contract

• The patients receive total hip or knee arthroplasty

• Epidural anesthesia administered

Exclusion Criteria:

• The patients' age out of range setting

• Forbidden to the administration of transcutaneous electrical acupoint stimulation

• Communication disorder

• The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting.

• The patients who attended another trial in the past three months

• Emergency surgery

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Delirium
• Pneumonia
• Postoperative Complications
• Postoperative Delirium
• Postoperative Infection
• Postoperative Nausea and Vomiting
• Postoperative Pneumonia
• Postoperative Recovery
• Postoperative Retention of Urine
• Thrombosis
• Urinary Retention
• Venous Thrombosis
• Vomiting

Intervention

Device:
• Transcutaneous Electrical Acupoint Stimulation
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
• Electroacupuncture
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
• sham Transcutaneous Electrical Acupoint Stimulation
The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.

Locations

Country	Name	City	State
China	Affiliated hospital of shandong university of traditional chinese medicine	Ji'nan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (10)

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):1 — View Citation

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. Review. — View Citation

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.1 — View Citation

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. — View Citation

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):e1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Compl — View Citation

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/s11655-007-90 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age in years	Once patients enrolled, the age (years) need to be recorded ahead of operation.	1 day
Other	ASA classification status	Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification.	1 day
Other	Gender	Once patients enrolled, the gender need to be recorded ahead of operation.	1 day
Other	Weight in kilograms	Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation.	1 day
Other	Height in meters	Once patients enrolled, the height (meters) need to be recorded ahead of operation.	1 day
Other	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
Primary	The postoperative recovery	Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.	7 days
Secondary	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
Secondary	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.	up to 7 days
Secondary	Postoperative complications	Record the incidence of any postoperative complications during 7 days	7 days
Secondary	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
Secondary	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