Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD
NCT ID: NCT03418194
Last Updated: 2019-05-13
Study Results
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Basic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2018-02-02
2018-06-30
Brief Summary
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Detailed Description
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The investigators plan to recruite 150 patients with coronary heart disease of both sexes, aged 65-80 yr, undergoing elective lumbar decompression and fusion internal fixation surgery. They will be randomly divided into 2 groups(n=75 each)using random number table : control group ( group C ) and TAES group (group T). Patients in group T receive TEAS (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery, the optimal intensity will be adjusted to maintain a slight twitching of the midfinger or ring finger (De-Qi response). Patients in group C receive electrode plate at the same acupoints without any electrical stimulation. Heart rate variability will be collected on 1 day before surgery, 1, 3 and 5d after surgery. 3mL of venous blood will be collected before the induction of anesthesia, 1, 3 and 5d after surgery, the serum will be isolated for the measurement of serum concentration of high-sensitive troponin T (hs-cTnT)、CK、CRP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAES group
Patients in group TAES group received transcutaneous acupoint electrical stimulation (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery,
transcutaneous acupoint electrical stimulation
Transcutaneous acupoint electrical stimulation(TAES) is a kind of noninvasive therapy similar to acupuncture and moxibustion. Its physiological effect is similar to that of electroacupuncture and hand acupuncture which is a Chinese traditonal therapy using acupuncture.
control group
Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.
sham transcutaneous acupoint electrical stimulation
Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.
Interventions
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transcutaneous acupoint electrical stimulation
Transcutaneous acupoint electrical stimulation(TAES) is a kind of noninvasive therapy similar to acupuncture and moxibustion. Its physiological effect is similar to that of electroacupuncture and hand acupuncture which is a Chinese traditonal therapy using acupuncture.
sham transcutaneous acupoint electrical stimulation
Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.
Eligibility Criteria
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Inclusion Criteria
* Slilent myocardial ischemia
* Remote myocardial infarction
Exclusion Criteria
* Have a history of cardiac surgery
* Frequent ventricular / atrial premature beats, atrial fibrillation and other serious arrhythmia
* Heart conduction diseases
* Antiarrhythmic drugs used
* Temporary and permanent pacemaker used
* Intraoperative blood loss\>800ml
65 Years
80 Years
ALL
No
Sponsors
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Hebei Medical University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiuli Wang, MD, PhD
Role: STUDY_CHAIR
Third Hospital of Hebei Medical Universit Department of Anesthesiology
Huizhou li, M.D
Role: STUDY_DIRECTOR
Third Hospital of Hebei Medical Universit Department of Anesthesiology
Chuan Wu, M.D
Role: PRINCIPAL_INVESTIGATOR
Third Hospital of Hebei Medical Universit Department of Anesthesiology
Locations
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Third Hospital of Hebei Medical Universit
Shijiazhuang, Hebei, China
Countries
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References
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Mazzeo AT, La Monaca E, Di Leo R, Vita G, Santamaria LB. Heart rate variability: a diagnostic and prognostic tool in anesthesia and intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):797-811. doi: 10.1111/j.1399-6576.2011.02466.x. Epub 2011 Jun 9.
Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
Other Identifiers
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TAESOFLHZ
Identifier Type: -
Identifier Source: org_study_id
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