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The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery

18 de abril de 2016 actualizado por: Jill Osborn, St. Paul's Hospital, Canada

The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery

Many drugs are used to prevent nausea and vomiting and pain after surgery. In this study the investigators will be looking at a drug, dexamethasone, which is commonly used to prevent nausea and vomiting and pain after surgery but has other side effects. Dexamethasone is a man-made drug that is commonly used during surgery but also can affect naturally occuring hormones. In this study the investigators will be looking at dexamethasone's effect on a number of naturally occuring hormones over a twenty four hour period after thyroid surgery. The investigators hypothesize that plasma cortisol levels will be decreased following administration of dexamethasone.

Descripción general del estudio

Estado

Retirado

Condiciones

Intervención / Tratamiento

Descripción detallada

Purpose To examine the effect of dexamethasone, on plasma cortisol levels, postoperative pain, nausea and vomiting in patients undergoing thyroid surgery.

Hypothesis That dexamethasone administered at induction of anesthesia will result in reduced plasma cortisol levels, postoperative pain, nausea and vomiting.

Justification Dexamethasone is a synthetic steroid medication used routinely to prevent nausea and vomiting in patients undergoing general anesthetic. Administration of exogenous steroids can suppress production of endogenous steroids including cortisol.

Currently, no data exists describing the degree of suppression of cortisol production by a single preoperative dose of dexamethasone. This information would guide physicians prescribing dexamethasone in the perioperative period.

Objectives To compare plasma cortisol levels in patients receiving dexamethasone versus placebo at induction of anesthesia. To investigate the effect of dexamethasone on postoperative pain, nausea and vomiting.

Research Methods A prospective, randomized, controlled, double-blinded study conducted at a single center. Thirty patients will be recruited and randomly assigned to dexamethasone or placebo groups, in accordance with sample size calculations. A placebo group is necessary to eliminate the effects of potential confounding factors.

Statistical Analysis An interim analysis will be conducted to confirm the sample size calculation. Plasma cortisol level will be analyzed using 2-way analysis of variance (ANOVA). Secondary outcome measures will be analyzed with appropriate parametric or nonparametric methods.

Tipo de estudio

Intervencionista

Fase

  • Fase 4

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.

Ubicaciones de estudio

  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 1Y6
        • St Paul's Hospital

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Female adult patients
  • Undergoing thyroid surgery
  • Euthyroid patients
  • Qualify as Class I or II according to the American Society of Anesthesiologists physical status classification system
  • Written informed consent

Exclusion Criteria:

  • Patients who have medical conditions associated with abnormalities of the hypothalamic-pituitary-adrenal axis which might alter plasma cortisol levels will be excluded from the study. This category includes the following conditions:

    1. A diagnosis of anxiety, depression or bipolar disorder
    2. Disorders of the central nervous system, pituitary gland or hypothalamic-pituitary-adrenal axis
    3. Diabetes mellitus
    4. Pathological conditions affecting cortisol metabolism, including liver disease
    5. Chronic renal failure
    6. Alcoholism
    7. Obesity
    8. Anorexia nervosa/ starvation
    9. High estrogen states, including pregnancy or use of OCP

  • Patients taking medication which might alter the normal function of the hypothalamic-pituitary-adrenal axis. This category includes:

    1. Patients taking exogenous steroid medication which would suppress normal cortisol production.
    2. Patients taking medication which alters steroid metabolism, including barbiturates, phenytoin and rifampicin.
  • Patients who have a known history of allergy, sensitivity or any other form of reaction to dexamethasone will be excluded from this study as they would be at risk of further reaction to dexamethasone.
  • Patients who have previously been included in this study will be excluded from further recruitment.
  • Patients who will undergo lateral neck dissection in association with the thyroid surgery will be excluded from the study as they will experience greater pain levels.
  • Patients who participate in other clinical studies during this study or in the 14 days prior to admission to this study 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

  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Otro: Placebo
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
Experimental: Dexametasona
Droga: Dexamethasone
One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Plasma Cortisol level.
Periodo de tiempo: One, eight and twenty-four hours following Dexamethasone administration.
One, eight and twenty-four hours following Dexamethasone administration.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Incidence of postoperative nausea and vomiting.
Periodo de tiempo: Twenty-four hours following surgery.
Twenty-four hours following surgery.
Pain intensity measured on the visual analogue scale.
Periodo de tiempo: Twenty-four hours following surgery
Twenty-four hours following surgery
Plasma Estradiol level.
Periodo de tiempo: One, eight and twenty-four hours following dexamethasone administration.
One, eight and twenty-four hours following dexamethasone administration.
Plasma Progesterone level.
Periodo de tiempo: One, eight and twenty-four hours following dexamethasone administration
One, eight and twenty-four hours following dexamethasone administration
Plasma ACTH level
Periodo de tiempo: One, eight and twenty-four hours following dexamethasone administration.
One, eight and twenty-four hours following dexamethasone administration.

Colaboradores e Investigadores

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

Patrocinador

St. Paul's Hospital, Canada

Investigadores

  • Investigador principal: Jill A Osborn, MD, St Paul's Hospital, Vancouver and University of British Columbia

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

1 de mayo de 2010

Finalización primaria (Anticipado)

1 de febrero de 2014

Finalización del estudio (Anticipado)

1 de febrero de 2016

Fechas de registro del estudio

Enviado por primera vez

8 de enero de 2010

Primero enviado que cumplió con los criterios de control de calidad

8 de enero de 2010

Publicado por primera vez (Estimar)

11 de enero de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de abril de 2016

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

18 de abril de 2016

Última verificación

1 de abril de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SPH-1515-DA

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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