The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery
The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery
研究概览
详细说明
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.
研究类型
阶段
- 第四阶段
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 1Y6
- St Paul's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
- A diagnosis of anxiety, depression or bipolar disorder
- Disorders of the central nervous system, pituitary gland or hypothalamic-pituitary-adrenal axis
- Diabetes mellitus
- Pathological conditions affecting cortisol metabolism, including liver disease
- Chronic renal failure
- Alcoholism
- Obesity
- Anorexia nervosa/ starvation
- 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:
- Patients taking exogenous steroid medication which would suppress normal cortisol production.
- 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
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
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实验性的：地塞米松
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One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Plasma Cortisol level.
大体时间：One, eight and twenty-four hours following Dexamethasone administration.
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One, eight and twenty-four hours following Dexamethasone administration.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Incidence of postoperative nausea and vomiting.
大体时间：Twenty-four hours following surgery.
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Twenty-four hours following surgery.
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Pain intensity measured on the visual analogue scale.
大体时间：Twenty-four hours following surgery
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Twenty-four hours following surgery
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Plasma Estradiol level.
大体时间：One, eight and twenty-four hours following dexamethasone administration.
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One, eight and twenty-four hours following dexamethasone administration.
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Plasma Progesterone level.
大体时间：One, eight and twenty-four hours following dexamethasone administration
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One, eight and twenty-four hours following dexamethasone administration
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Plasma ACTH level
大体时间：One, eight and twenty-four hours following dexamethasone administration.
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One, eight and twenty-four hours following dexamethasone administration.
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合作者和调查者
调查人员
- 首席研究员：Jill A Osborn, MD、St Paul's Hospital, Vancouver and University of British Columbia
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Dexamethasone的临床试验
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Medical University of Lodz招聘中
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Federal University of São PauloFaculdade de Ciências Médicas da Santa Casa de São Paulo未知