Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section (TEAS)
7 augusti 2017 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
150
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Sham Comparator: 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.
Andra namn:
|
|
Placebo-jämförare: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
This is a composite outcome to estimate the gastrointestinal motility function
|
Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Electrogastrogram
Tidsram: The first and second days after surgery
|
The first and second days after surgery
|
|
|
Rate of nausea, vomiting, cramping abdominal pain, abdominal distension
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
This is a composite outcome to estimate the complication of digestive system
|
Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
|
length of postoperative hospital stay
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
|
|
Quality of life during 30 days after surgery
Tidsram: One month
|
This is a scale to evaluate the quality of life after surgery
|
One month
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Qiang Wang, Xijing Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2015
Primärt slutförande (Faktisk)
1 mars 2016
Avslutad studie (Faktisk)
26 mars 2016
Studieregistreringsdatum
Först inskickad
2 april 2015
Först inskickad som uppfyllde QC-kriterierna
14 april 2015
Första postat (Uppskatta)
15 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Xijing H (XijingH)
- mazuike (Annan identifierare: Xijing Hospital)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .