The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels After Gynecologic Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Post operative cortisol level
研究概览
简要总结
Dexamethasone is a synthetic corticosteroid that has been proven to be effective and relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV).
However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this question, the investigators will conduct a randomized, double-blinded placebo-controlled trial with two different doses of dexamethasone in women undergoing elective gynecologic laparotomy.
详细描述
Hypothesis:
The investigators hypothesize that preoperative administration of intravenous dexamethasone in non-cancer gynecologic laparotomy will decrease postoperative cortisol levels in a dose-dependent fashion.
Objectives:
To compare the post-operative plasma cortisol and glucose level in patients receiving various single doses of dexamethasone versus placebo at the start of gynecologic laparotomy.
To assess the dose-dependent effect of dexamethasone on postoperative pain, nausea and vomiting in this particular context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 80 years-old scheduled for non-oncologic gynecologic laparotomy, including fibroid myomectomy, hysterectomy and endometrioma resection
排除标准
- •Communication barrier rendering informed consent inadequate
- •Pregnancy
- •Diabetes mellitus
- •Chronic or acute renal failure
- •Chronic or acute hepatic failure
- •History of chronic opioid use
- •History of corticosteroid use more than 3 weeks in the last 6 months (inhaled, oral or intravenous)
- •History of disorders of the hypothalamus, pituitary gland and/or adrenal glands
- •History of depression and/or bipolar disorder
- •History of allergy or sensitivity to dexamethasone or any medication used in the standardised anesthetic care
- •American Society of Anesthesiologists Physical Status class of 3 and above.
研究组 & 干预措施
Placebo
Placebo group
干预措施: Saline (Drug)
4 mg dexamethasone
4 mg dexamethasone group
干预措施: Dexamethasone (Drug)
Dexamethasone 8 mg
Dexamethasone 8 mg group
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Post operative cortisol level
时间窗: 24h post-operation
The primary outcome is the plasma cortisol level at 24h post-operation.
次要结局
- plasma cortisol(72 hours post-operatively)
- Blood glucose level(72 hours post-operatively)
- Post operative pain score(72 hours post operatively)
- Post operative nausea and vomiting scale(72 hours post-operatively)
研究者
William Li Pi Shan
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre