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Electrical Acupoint Stimulation for Postoperative Recovery (EAS)

Primary Purpose

Postoperative Complications, Postoperative Nausea and Vomiting, Postoperative Infection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous Electrical Acupoint Stimulation
Electroacupuncture
sham Transcutaneous Electrical Acupoint Stimulation
Sponsored by
Shandong University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring Acupoint Stimulation, postoperative recovery, Postoperative Complications, Peri-operation

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated hospital of shandong university of traditional chinese medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

TEAS group

Electroacupuncture group

sham TEAS group

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The adverse event
Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.
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.
Postoperative complications
Record the incidence of any postoperative complications during 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.
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.

Full Information

First Posted
August 3, 2017
Last Updated
March 30, 2018
Sponsor
Shandong University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03249701
Brief Title
Electrical Acupoint Stimulation for Postoperative Recovery
Acronym
EAS
Official Title
Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Electroacupuncture group
Arm Type
Placebo Comparator
Arm Description
Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
Arm Title
sham TEAS group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Acupoint Stimulation
Intervention Description
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Intervention Description
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
Intervention Type
Device
Intervention Name(s)
sham Transcutaneous Electrical Acupoint Stimulation
Intervention Description
The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.
Primary Outcome Measure Information:
Title
The postoperative recovery
Description
Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
The adverse event
Description
Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.
Time Frame
7 days
Title
The level of stress response
Description
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.
Time Frame
up to 7 days
Title
Postoperative complications
Description
Record the incidence of any postoperative complications during 7 days
Time Frame
7 days
Title
The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10
Description
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.
Time Frame
up to 7 days
Title
The level of inflammatory response by C-reactive protein
Description
Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L.
Time Frame
up to 7 days
Other Pre-specified Outcome Measures:
Title
Age in years
Description
Once patients enrolled, the age (years) need to be recorded ahead of operation.
Time Frame
1 day
Title
ASA classification status
Description
Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification.
Time Frame
1 day
Title
Gender
Description
Once patients enrolled, the gender need to be recorded ahead of operation.
Time Frame
1 day
Title
Weight in kilograms
Description
Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation.
Time Frame
1 day
Title
Height in meters
Description
Once patients enrolled, the height (meters) need to be recorded ahead of operation.
Time Frame
1 day
Title
BMI in kg/m^2
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang weiliang, MD
Phone
086-0531-68617021
Ext
6114
Email
hezhangweiliang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Su Fan, MD
Phone
086-0531-68617023
Ext
6114
Email
boatsail@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Fan, MD
Organizational Affiliation
Shandong University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated hospital of shandong university of traditional chinese medicine
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang weiliang, MD
Phone
086-0531-68617021
Ext
6114
Email
hezhangweiliang@163.com
First Name & Middle Initial & Last Name & Degree
Su Fan, MD
Phone
086-0531-68617023
Ext
6114
Email
boatsail@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
IPD Sharing Time Frame
Data will be available within 6 months of study completion, forever.
IPD Sharing Access Criteria
Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.
Citations:
PubMed Identifier
20084351
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.
Results Reference
result
PubMed Identifier
25048507
Citation
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.
Results Reference
result
PubMed Identifier
20669525
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. Available from http://www.ncbi.nlm.nih.gov/books/NBK44178/
Results Reference
result
PubMed Identifier
24693389
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):e12268. doi: 10.5812/ircmj.12268. Epub 2013 Dec 5.
Results Reference
result
PubMed Identifier
25375388
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.
Results Reference
result
PubMed Identifier
25355258
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.1672-7347.2014.10.011. Chinese.
Results Reference
result
PubMed Identifier
15344424
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. doi: 10.1142/S0192415X04002065.
Results Reference
result
PubMed Identifier
15992223
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. doi: 10.1089/acm.2005.11.407.
Results Reference
result
PubMed Identifier
26170873
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 Complement Alternat Med. 2015;2015:324360. doi: 10.1155/2015/324360. Epub 2015 Jun 11.
Results Reference
result
PubMed Identifier
18219451
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/s11655-007-9006-2.
Results Reference
result

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Electrical Acupoint Stimulation for Postoperative Recovery

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