Electrical Acupoint Stimulation for Postoperative Recovery

NCT ID: NCT03249701

Last Updated: 2018-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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TEAS group

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.

Group Type EXPERIMENTAL

Transcutaneous Electrical Acupoint Stimulation

Intervention Type DEVICE

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

Electroacupuncture group

Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.

Group Type PLACEBO_COMPARATOR

Electroacupuncture

Intervention Type DEVICE

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

sham TEAS group

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.

Group Type SHAM_COMPARATOR

sham Transcutaneous Electrical Acupoint Stimulation

Intervention Type DEVICE

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

Interventions

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Transcutaneous Electrical Acupoint Stimulation

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

Intervention Type DEVICE

Electroacupuncture

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

Intervention Type DEVICE

sham Transcutaneous Electrical Acupoint Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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weiliang zhang

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Su Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Locations

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Affiliated hospital of shandong university of traditional chinese medicine

Ji'nan, Shandong, China

Site Status

Countries

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China

Central Contacts

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zhang weiliang, MD

Role: CONTACT

086-0531-68617021 ext. 6114

Su Fan, MD

Role: CONTACT

086-0531-68617023 ext. 6114

Facility Contacts

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zhang weiliang, MD

Role: primary

086-0531-68617021 ext. 6114

Su Fan, MD

Role: backup

086-0531-68617023 ext. 6114

References

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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.

Reference Type RESULT
PMID: 20084351 (View on PubMed)

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.

Reference Type RESULT
PMID: 25048507 (View on PubMed)

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/

Reference Type RESULT
PMID: 20669525 (View on PubMed)

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.

Reference Type RESULT
PMID: 24693389 (View on PubMed)

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.

Reference Type RESULT
PMID: 25375388 (View on PubMed)

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.

Reference Type RESULT
PMID: 25355258 (View on PubMed)

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.

Reference Type RESULT
PMID: 15344424 (View on PubMed)

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.

Reference Type RESULT
PMID: 15992223 (View on PubMed)

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.

Reference Type RESULT
PMID: 26170873 (View on PubMed)

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.

Reference Type RESULT
PMID: 18219451 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SZH-A-20170501-R2

Identifier Type: -

Identifier Source: org_study_id

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