A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual analog scale score for anxiety
研究概览
简要总结
Patients are often anxious immediately before surgery. The investigators hypothesis is that a warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.
详细描述
The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as required; and 3) forced-air warming, a cotton blanket and reassurance as required. The primary endpoint is a visual analog scale of anxiety.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 70 years
- •male and female
- •presenting for elective surgery
- •requiring general anaesthesia
排除标准
- •Cardiothoracic and intracranial surgery
- •Day case surgery
- •Pre-existing anxiety disorder
- •Patients on psychotropic drugs preoperatively Febrile patients T > 37.5 degrees Celsius Allergy to midazolam Obstructive Sleep Apnoea diagnosed on sleep study
研究组 & 干预措施
1
Single un-warmed cotton blanket over body and limbs, and reassurance, during preoperative period in anaesthetic room
干预措施: Normal Saline (Drug)
2
Single un-warmed cotton blanket over body and limbs, reassurance and intravenous midazolam 30 µg/kg i.v, during preoperative period in anaesthetic room
干预措施: Midazolam (Drug)
3
Single un-warmed cotton blanket, reassurance and forced-air warming with a Bair Hugger, during preoperative period in anaesthetic room
干预措施: Bair Hugger (Device)
结局指标
主要结局
Visual analog scale score for anxiety
时间窗: During immediate pre-operative phase
次要结局
- Thermal comfort(During immediate pre-operative phase)
- Recovery from anaesthesia(During immediate post-operative phase)
- Satisfaction with care(During immediate post-operative phase)