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Acupuncture for Prevention of Postoperative Nausea and Vomiting (PONV)

30 de abril de 2021 actualizado por: Alirıza Erdoğan, Nigde Omer Halisdemir University

The Comparison of P6+ST36 Combination Acupuncture Therapy With P6 Alone Acupuncture and Standard Treatment in Postoperative Nausea and Vomiting

The aim of this study is to compare the single point stimulation (P6) and double point stimulation (P6+ST36) performed before anesthesia induction with standard treatment in terms of PONV development and postoperative anti-emetic requirement in patients undergoing laparoscopic cholecystectomy.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Postoperative nausea and vomiting (PONV) is encountered in 20-30% of patients undergoing surgery. PONV is a costly medical condition in financial and emotional aspects by causing serious complications like elongation of hospital stay, postoperative bleeding, aspiration pneumonia and electrolyte imbalances. In high risk individuals and operations, it can be encountered in up to 80% of patients. The risk factors for PONV development in adults are female gender, previous PONV and/or motion sickness, non-smoking and younger age. Additionally, it has been reported that some surgery types, especially, laparoscopic cholecystectomy and gynecologic surgeries along with the anesthetic agent, the duration of anesthesia and postoperative opioid use also have direct effects on PONV development.

According to the 4th consensus guidelines for the management of PONV updated in 2020, in patients with one or more risk factors, a multimodal prophylaxis using a combination of at least 2 of the following methods; 5-HT3 receptor antagonists, corticosteroids, anti-histaminics, dopamine antagonists, propofol anesthesia, NK-1 receptor antagonists, anti-cholinergics and acupuncture.

Following the declaration of acupuncture as an effective treatment option for PONV in 1999 NIH Consensus Conference, studies about this topic gained speed and many high quality randomized controlled clinic studies were performed. In one of the most comprehensive reviews published in 2015, it is stated that stimulation of P6 acupuncture point remarkably reduce the risk of PONV development, significantly decrease the amount of postoperative anti-emetic requirement, provide similar PONV prophylaxis with different pharmacoprophylactic agents (metoclopramide, cyclizine, prochlorperazine, droperidol, ondansetron and dexamethasone) and have similar post-operative anti-emetic requirement with pharmacologic agents. In the same Cochrane analysis, it is clearly stated that studies enrolling groups of sham acupuncture for P6 are redundant and would not go any further than duplicating the available well-established information. In this aspect, the proposed study design is comparison between treatment groups.

PONV has a multifactorial ethology. It has been postulated that it occurs as a result of activation of emetic center in the brain stem by stimulation of various peripheral receptors as well as central receptors including the chemoreceptor trigger zone in the postrema region. Following activation, the response of emetic center for anti-emetic agents is rather weak and consequently this complicates PONV treatment. Acupuncture is a kind of periphery sensory stimulus and has modulatory effects on the emetic center in the brain stem via neuronal pathways. This neural modulation is thought to be the result of communication between cerebellum and insula. As a result of these mechanisms of action, performing acupuncture before the induction of anesthesia provides more effective PONV prophylaxis.

Pharmacologic anti-emetic agents increase treatment costs as well as bear some adverse effects. The clinical condition created by PONV and increasing dissatisfaction due to the adverse effects of the pharmacologic agents urge both patients and clinicians pursuing non-pharmacologic modalities with proven efficiency, like acupuncture.

Therefore, it is essential to develop a standard, simple, effective prophylaxis protocol with high patient compliance and without ad verse effects, especially in patients with high risk for PONV. In the literature various different technique and materials were used for acupuncture stimulation. Unfortunately, a standard is not present for the metal of the needle, the length of the needle, the depth of immersion, the technique of stimulation and in most of the studies these features are not specified at all. Meanwhile, although P6 is the most studied point for PONV, there are encouraging evidence that some other points, like ST36 or LI4, might be incorporated into the PONV protocol. ST36 have potential effects in balancing gastrointestinal motility by modulating gastric motility via vagovagal and sympathetic reflex arches. Moreover, P6 in combination with ST36 has been successful in treatment of hiccups, recently.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

105

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Niğde, Pavo
        • Reclutamiento
        • Niğde Ömer Halisdemir University Training and Research Hospital
        • Contacto:

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

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Women between 18-65 years old, who have ASA scores of I-II-III and who are planned to undergo elective laparoscopic cholecystectomy.

Exclusion Criteria:

  • Pregnant women
  • Lactating women
  • Women with steel hypersensitivity
  • Mental retarded patients
  • Patients with psychological disorders and neurologic sequel
  • Additionally, patients who;
  • have nausea/vomiting, consume anti-emetic or emetogenic drugs, alcohol, opioid drugs, glucocorticoid drug and have acupuncture treatment for any reason 72 hours prior to surgery
  • have skin reactions at the site of acupuncture application
  • had intraoperative gangrenous cholecystitis, gall bladder perforation, malignant pathological outcome
  • were admitted to intensive care unite
  • had to convert to open surgery will be excluded.

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: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Standard Treatment
Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia.
Comparador activo: Single point (P6) Acupuncture

Prior to the anesthesia induction, the same certified medical doctor will perform a standard acupuncture protocol to the P6 point bilaterally. For P6 acupuncture stimulation 0,25x25mm steel needles will be immersed for 2cm. For stimulation, the needles will be turned clock-wise 3 times. This stimulation will be repeated for 3 times with 10 seconds intervals. The needles will be held in place for 20 minutes and will be removed afterwards.

Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia.

A standardized acupuncture protocol will be administered
Experimental: Double point (P6+ST36) Acupuncture
Prior to the anesthesia induction, the same certified medical doctor will perform a standard acupuncture protocol both to the P6 and ST36 points bilaterally. For P6 acupuncture stimulation 0,25x25mm steel needles will be immersed for 2cm. For ST6 acupuncture stimulation 0,25x50mm steel needles will be immersed for 5cm. For stimulation, the needles will be turned clock-wise 3 times. This stimulation will be repeated for 3 times with 10 seconds intervals. The needles will be held in place for 20 minutes and will be removed afterwards. Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia.
A standardized acupuncture protocol will be administered

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PONV prophylaxis
Periodo de tiempo: 12 months
The frequency of PONV development
12 months
Postoperative anti-emetic requirement
Periodo de tiempo: 12 months
The amount of anti-emetic agent administered postoperatively
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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 mayo de 2021

Finalización primaria (Anticipado)

1 de mayo de 2022

Finalización del estudio (Anticipado)

1 de mayo de 2022

Fechas de registro del estudio

Enviado por primera vez

26 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

26 de abril de 2021

Publicado por primera vez (Actual)

29 de abril de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de mayo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

30 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 14.04.2021/28

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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