Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
研究概览
简要总结
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
详细描述
This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy
排除标准
- •Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
- •Regional anesthesia for surgical procedure
- •Chronic pain requiring opioid treatment daily
- •History of allergy to the study medication
- •Severe renal and liver disease
- •Pregnancy
- •Non English speaking
- •Psychiatric disorder that will preclude completion of questionnaires
- •Minor surgery that does not involve overnight admission
- •Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
- •Hypersensitivity reaction to steroids
- •Evidence of systemic fungal infection
- •Evidence of any systemic infection
- •Uncontrolled diabetes
研究组 & 干预措施
Dexamethasone
Dexamethasone
干预措施: Dexamethasone (Drug)
Placebo
Sterile normal saline solution
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
时间窗: up to 20-24 hours after surgery
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
次要结局
- To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.(20-24 hours after surgery)