Electrical Acupoint Stimulation for Postoperative Recovery

NCT03249701 | Unknown DMC

• 1 other identifier: SZH-A-20170501-R2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications; Postoperative Nausea and Vomiting; Postoperative Infection; Postoperative Delirium; Postoperative Pneumonia; Deep Vein Thrombosis; Postoperative Retention of Urine; Postoperative Recovery

Keywords

Acupoint Stimulation; postoperative recovery; Postoperative Complications; Peri-operation

Outcome Measures

Primary Outcomes (1)

• The postoperative recovery

  Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.

  7 days

Secondary Outcomes (5)

• The adverse event

  7 days

• The level of stress response

  up to 7 days

• Postoperative complications

  7 days

• The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10

  up to 7 days

• The level of inflammatory response by C-reactive protein

  up to 7 days

Other Outcomes (6)

• Age in years

  1 day

• ASA classification status

  1 day

• Gender

  1 day

Study Arms (3)

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.

Device: Transcutaneous Electrical Acupoint Stimulation

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.

Device: Electroacupuncture

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.

Device: sham Transcutaneous Electrical Acupoint Stimulation

Interventions

Transcutaneous Electrical Acupoint Stimulation DEVICE

The intervention will be administered by electrical acupoint machine, the brand is Great Wall.

TEAS group

Electroacupuncture DEVICE

The intervention will be administered by electrical acupoint machine, the brand is Great Wall.

Electroacupuncture group

sham Transcutaneous Electrical Acupoint Stimulation DEVICE

The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.

sham TEAS group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Agree to sign the contract
• The patients receive total hip or knee arthroplasty
• Epidural anesthesia administered

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University of Traditional Chinese Medicine: lead

Study Sites (1)

Affiliated hospital of shandong university of traditional chinese medicine

Ji'nan, Shandong, 250011, China

Location

Related Publications (10)

• 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.

  PMID: 20084351 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.

  PMID: 25048507 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/

  PMID: 20669525 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.

  PMID: 24693389 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.

  PMID: 25375388 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.

  PMID: 25355258 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.

  PMID: 15344424 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.

  PMID: 15992223 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.

  PMID: 26170873 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.

  PMID: 18219451 RESULT

MeSH Terms

Conditions

Postoperative Complications; Postoperative Nausea and Vomiting; Emergence Delirium; Venous Thrombosis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Su Fan, MD

  Affiliated Hospital of Shandong University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang weiliang, MD

CONTACT

086-0531-68617021; hezhangweiliang@163.com

Su Fan, MD

CONTACT

086-0531-68617023; boatsail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 15, 2017
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: October 30, 2019
• Last Updated: April 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion, forever.
• Access Criteria: Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.

Locations

CN (1)