The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Plasma Cortisol level.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Plasma Cortisol level.
时间窗: One, eight and twenty-four hours following Dexamethasone administration.
次要结局
- Plasma Estradiol level.(One, eight and twenty-four hours following dexamethasone administration.)
- Incidence of postoperative nausea and vomiting.(Twenty-four hours following surgery.)
- Pain intensity measured on the visual analogue scale.(Twenty-four hours following surgery)
- Plasma Progesterone level.(One, eight and twenty-four hours following dexamethasone administration)
- Plasma ACTH level(One, eight and twenty-four hours following dexamethasone administration.)
研究者
Jill Osborn
Anesthesiologist
St. Paul's Hospital, Canada