Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of recovery 40 (QoR-40)
研究概览
简要总结
The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).
详细描述
There has been a public outcry regarding the continuing rise of health care expenditures. In 1997, the estimated costs of surgery for pelvic organ prolapse (POP) were $ 100.1 million. It is important to identify interventions that would improve the QoR in this patient population and to speed-up postoperative recovery. As most of these surgeries are performed in an outpatient manner as a 23 hour observation, improved recovery may also speed discharge and free-up valuable hospital resources.
Patients will receive either Dexamethasone or placebo ( normal saline) at the time of induction of general anesthesia. QoR questionnaires, Pain scale and postoperative nausea and vomiting scale (PONV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over the age of 18
- •Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy
- •American Society of Anesthesiologists (ASA) class 1-2
排除标准
- •Daily use of steroids, antiemetics in the month prior to surgery
- •Chronic pain requiring daily opioid treatment
- •History of allergy/intolerance to Dexamethasone
- •ASA class 3
- •Numerical Pain score (NPS) of more than 4 at baseline
- •Renal/Liver disease
- •Diabetes mellitus
- •Inability to answer questionnaires
- •Any systemic infections
- •Immuno compromised status
研究组 & 干预措施
Dexamethasone
Dexamethasone is a potent corticosteroid that has been widely used for chemotherapy induced nausea and vomiting. The mechanism of action is not completely understood. It has been proposed that a single dose may hinder the production and release of anti-inflammatory mediators. Dexamethasone also has a central antiemetic effect by inhibition of prostaglandin and/or release of endogenous opioids. A recent metanalysis concluded that Dexamethasone administration at induction is safe.
We will be using a 8mg dose of Dexamethasone, that is equivalent to 2ml of injectable drug.
干预措施: Dexamethasone (Drug)
Saline
Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.
干预措施: Normal saline (Drug)
结局指标
主要结局
Quality of recovery 40 (QoR-40)
时间窗: baseline, 24 hours, 6 weeks
Quality of Recovery 40 will be recorded at baseline, 24 hours and 6 weeks. The change in the mean scores will be computed for each group. The primary endpoint of change in QoR from baseline will be analyzed through t- test.
次要结局
- Numerical Pain Scale(baseline, 24 hours, 6 weeks)
- Postoperative Nausea Vomiting Scale(6 weeks)
研究者
Eric Hurtado
Principal Investigator
The Cleveland Clinic