Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section (TEAS)
7 augustus 2017 bijgewerkt door: wangqiang, Xijing Hospital
Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group.
Studie Overzicht
Gedetailleerde beschrijving
Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases.Clinical evidence supports the efficacy of acupuncture treatment in many applications.
Some previous studies reported that stimulation at some acupoint exerted good effects on the digestive system.Compared with acupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique that has similar effects to acupuncture.We hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after Cesarean section.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
150
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- ASA physical status 1or2, scheduled for elective cesarean section under combined spinal epidural anesthesia
- Gestational age ≥38 weeks
- Provide written informed consent
Exclusion Criteria:
- ASA status≥Ⅲ
- Patients undergoing surgery within 12 h of admission to hospital
- Patients with fetal anomaly，medical or obstetric complications such as Diabetes mellitus、Hypertension、Obesity(BMW≥35)
- Patients suffered from drug addiction or impaired mental state
- Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease.
- Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
- Patients with experience of transcutaneous electrical stimulation treatment
- Participate in the other clinical trial 3 months before the enrollment
- Not suitable to participate in this experiment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: TEAS group
TEAS are performed by a specific investigator on the specially acupoint.
|
According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves.
Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation.
Andere namen:
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Sham-vergelijker: Sham group
TEAS are performed by a specific investigator on the non-acupoint.
|
According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves.
Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation.
Andere namen:
|
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Placebo-vergelijker: Control group
Only place cutted electrodes but do not give any electrical stimulation.
|
According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves.
Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time to the presence of bowel sound, time to the first passage of flatus, time to the first passage of stool , time to the start of regular diet
Tijdsspanne: Participants will be followed for the duration of hospital stay, an expected average of 5 days
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This is a composite outcome to estimate the gastrointestinal motility function
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Participants will be followed for the duration of hospital stay, an expected average of 5 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Electrogastrogram
Tijdsspanne: The first and second days after surgery
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The first and second days after surgery
|
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Rate of nausea, vomiting, cramping abdominal pain, abdominal distension
Tijdsspanne: Participants will be followed for the duration of hospital stay, an expected average of 5 days
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This is a composite outcome to estimate the complication of digestive system
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Participants will be followed for the duration of hospital stay, an expected average of 5 days
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length of postoperative hospital stay
Tijdsspanne: Participants will be followed for the duration of hospital stay, an expected average of 5 days
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Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
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Quality of life during 30 days after surgery
Tijdsspanne: One month
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This is a scale to evaluate the quality of life after surgery
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One month
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Qiang Wang, Xijing Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
- Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
- Cheong KB, Zhang JP, Huang Y. The effectiveness of acupuncture in postoperative gastroparesis syndrome--a systematic review and meta-analysis. Complement Ther Med. 2014 Aug;22(4):767-86. doi: 10.1016/j.ctim.2014.05.002. Epub 2014 May 12.
- Oshima M, Aoyama K, Warabi K, Akazawa T, Inada E. Electrogastrography during and after cesarean delivery. J Anesth. 2009;23(1):75-9. doi: 10.1007/s00540-008-0692-5. Epub 2009 Feb 22.
- Dresang LT, Leeman L. Cesarean delivery. Prim Care. 2012 Mar;39(1):145-65. doi: 10.1016/j.pop.2011.11.007.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2015
Primaire voltooiing (Werkelijk)
1 maart 2016
Studie voltooiing (Werkelijk)
26 maart 2016
Studieregistratiedata
Eerst ingediend
2 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
14 april 2015
Eerst geplaatst (Schatting)
15 april 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 augustus 2017
Laatste update ingediend die voldeed aan QC-criteria
7 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Xijing H (XijingH)
- mazuike (Andere identificatie: Xijing Hospital)
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