Assessment of Two Modes of Premedication in Surgery - PREMED Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 8
- 主要终点
- anxiety scales
研究概览
简要总结
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.
- one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
- one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
- one receiving placebo before sleep and alprazolam (0.5 mg)at awakening
double blind, randomized controlled study
详细描述
Eligibility:
- 18 to 65 years old
- elective surgery
- in-hospital preoperative night
Outcome measures:
- anxiety scales
- demographic data
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years old
- •elective surgery
- •in-hospital night before surgery
排除标准
- •myasthenia gravis
- •chronic intake of psychotropic drugs
- •opiates intake
- •severe obstructive sleep apnea
- •intracranial hypertension
- •morbid obesity
- •myasthenia gravis
- •acute severe medical disorder
- •non health insurance coverage
- •protected patients by law
- •pregnancy
- •non French speaking
研究组 & 干预措施
zopiclone
zopiclone given before sleep, the day before surgery (placebo given at awakening the day of surgery)
干预措施: Zopiclone (Drug)
alprazolam
given at awakening, the day of surgery (placebo given before sleep, the day before surgery)
干预措施: Alprazolam (Drug)
placebo
Placebo given night before operation and the morning of operation
干预措施: placebo (Drug)
结局指标
主要结局
anxiety scales
时间窗: duration of the study : 12 hours (one evaluation on late afternoon the day before surgery and the second evaluation on arrival to operating room)
\* The day before surgery (late afternoon) : patient's self rating of anxiety and desire of information regarding upcoming surgery (Amsterdam patient anxiety and information scale, APAIS) \* On arrival to the operating room : Recording of the level of declared anxiety (numeric scale similar to that corresponding of the "anxiety component of the APAIS scale)
次要结局
- markers of stress(on arrival to operating room (one single recording))