Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section (TEAS)
7 de agosto de 2017 actualizado por: 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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
150
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: TEAS group
TEAS are performed by a specific investigator on the specially acupoint.
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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.
Otros nombres:
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Comparador falso: 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.
Otros nombres:
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Comparador de placebos: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
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Participants will be followed for the duration of hospital stay, an expected average of 5 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Electrogastrogram
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Qiang Wang, Xijing Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2015
Finalización primaria (Actual)
1 de marzo de 2016
Finalización del estudio (Actual)
26 de marzo de 2016
Fechas de registro del estudio
Enviado por primera vez
2 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
14 de abril de 2015
Publicado por primera vez (Estimar)
15 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Xijing H (XijingH)
- mazuike (Otro identificador: Xijing Hospital)
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