Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual analogue pain scale at rest and on movement postoperatively
研究概览
简要总结
Fracture neck of femur is a common cause of hospital admission in the elderly and requires operative fixation.
Dexamethasone has the potential of inhibiting cortisol secretion. In addition, preoperative glucocorticoids improve analgesia and decrease opioid consumption with reduction in associated side effects in a variety of clinical settings.
The investigators hypothesis was that a single dose of preoperative dexamethasone enhance postoperative analgesia and attenuates the inflammatory response in patients undergoing operative fixation of fractured neck of femur, in a prospective, randomized, placebo controled trial.
详细描述
Having obtained ethical approval and written informed consent from each, 40 patients scheduled to undergo operative fixation of fractured neck of femur will be randomized using sealed envelopes to two groups.
Patients in the Dexamethasone group receive a single dose of 0.1 mg/kg dexamethasone iv. preoperative, patients in the Placebo group receive the same amount of Normal Saline. The anaesthetic technique is standardized, salive samples, blood samples are taken and pain scores are measured on a visual analog scale postoperatively at several timepoints.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •above 65 years
- •ASA I-III patients
排除标准
- •patient refusal
- •outside age range
- •coagulation disorders
- •depression
- •Cushing syndrome
- •endocrine disorders
- •corticosteroid treatment in the last 4 month
- •head injury or associated injuries
- •Mini Mental Scores < 25
研究组 & 干预措施
Dexamethasone, 0.1 mg/kg
The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.
干预措施: Dexamethasone acetate (Drug)
Placebo
In the Placebo group the patients get 0.1 ml/kg normal saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analogue pain scale at rest and on movement postoperatively
时间窗: Postoperative in recovery, 6, 12, 24, 48, 72 hourly
次要结局
未报告次要终点
研究者
Szilard Szucs
Clinical Tutor in Anaesthesia
Cork University Hospital