Postoperative ComplicationsEASNCT03249701
Electrical Acupoint Stimulation for Postoperative Recovery
A study testing Transcutaneous Electrical Acupoint Stimulation and Electroacupuncture in people with Postoperative Complications and Postoperative Nausea and Vomiting, run by Shandong University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Postoperative Complications, Postoperative Nausea and Vomiting, Postoperative Infection
- What is being tested?
- Transcutaneous Electrical Acupoint Stimulation and Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Agree to sign the contract
- The patients receive total hip or knee arthroplasty
- Epidural anesthesia administered
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated hospital of shandong university of traditional chinese medicine
Ji'nan, Shandong, 250011
zhang weiliang, MD, 086-0531-68617021 ext. 6114, hezhangweiliang@163.com
Su Fan, MD, 086-0531-68617023 ext. 6114, boatsail@163.com
About this study
Official title: Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.
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.
Read the 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.
- Conditions
- Postoperative Complications, Postoperative Nausea and Vomiting, Postoperative Infection, Postoperative Delirium, Postoperative Pneumonia, Deep Vein Thrombosis
- Being tested
- Transcutaneous Electrical Acupoint Stimulation, Electroacupuncture, sham Transcutaneous Electrical Acupoint Stimulation
- Keywords
- Acupoint Stimulation, postoperative recovery, Postoperative Complications, Peri-operation
- Medical subject headings
- Postoperative Complications, Postoperative Nausea and Vomiting, Emergence Delirium, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Acupoint StimulationDevice
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
ElectroacupunctureDevice
The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
sham Transcutaneous Electrical Acupoint StimulationDevice
The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: sham Transcutaneous Electrical Acupoint Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative recovery
Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.
Measured: 7 days
Secondary outcomes (5)
The adverse event
Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.
Measured: 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.
Measured: up to 7 days
Postoperative complications
Record the incidence of any postoperative complications during 7 days
Measured: 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.
Measured: 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.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 May 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, weiliang zhang, Shandong University of Traditional Chinese Medicine
- Investigators
- Su Fan, MD, Principal investigator, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249701
- Sponsor's protocol ID
- SZH-A-20170501-R2
- Acronym
- EAS
- Status last verified
- Mar 2018
- First submitted
- 3 Aug 2017
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
Publications
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.
PubMed 20084351Choi 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.
PubMed 25048507Office 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/
PubMed 20669525Montazeri 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.
PubMed 24693389Sorrell 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.
PubMed 25375388Ge 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.
PubMed 25355258Tsay 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.
PubMed 15344424Kabalak 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.
PubMed 15992223Yao 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.
PubMed 26170873Zheng 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.
PubMed 18219451
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.
- ClinicalTrials.gov ID
- NCT03249701
- Acronym / sponsor ID
- EAS / SZH-A-20170501-R2
- Conditions
- Postoperative Complications, Postoperative Nausea and Vomiting, Postoperative Infection, Postoperative Delirium, Postoperative Pneumonia, Deep Vein Thrombosis
- Keywords
- Acupoint Stimulation, postoperative recovery, Postoperative Complications, Peri-operation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shandong University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: Transcutaneous Electrical Acupoint StimulationTranscutaneous 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 | Device: ElectroacupunctureHand-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 | Device: sham Transcutaneous Electrical Acupoint StimulationSham 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Agree to sign the contract
- The patients receive total hip or knee arthroplasty
- Epidural anesthesia administered
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Acupoint StimulationThe intervention will be administered by electrical acupoint machine, the brand is Great Wall. | Device | TEAS group |
| ElectroacupunctureThe intervention will be administered by electrical acupoint machine, the brand is Great Wall. | Device | Electroacupuncture group |
| sham Transcutaneous Electrical Acupoint StimulationThe intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized. | Device | sham TEAS group |
Primary outcome
The postoperative recovery
Time frame: 7 days
Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.
5 secondary outcomes
The adverse event
Time frame: 7 days
The level of stress response
Time frame: up to 7 days
Postoperative complications
Time frame: 7 days
The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10
Time frame: up to 7 days
The level of inflammatory response by C-reactive protein
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Results publication: PubMed 20084351Coburn 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 publication: PubMed 25048507Choi 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 publication: PubMed 20669525Office 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 publication: PubMed 24693389Montazeri 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 publication: PubMed 25375388Sorrell 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 publication: PubMed 25355258Ge 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 publication: PubMed 15344424Tsay 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 publication: PubMed 15992223Kabalak 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 publication: PubMed 26170873Yao 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 publication: PubMed 18219451Zheng 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.
- Individual participant dataSharing planned: Yes. IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Fan, MD principal investigator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Acupoint Stimulation and Electroacupuncture in people with Postoperative Complications and Postoperative Nausea and Vomiting, run by Shandong University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang weiliang, MD (086-0531-68617021 ext. 6114, hezhangweiliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative recovery (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249701, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.