CTRI/2025/01/079825尚未招募不适用
Premedication before surgeries: A Comparison of Zopiclone, Melatonin, and Alprazolam on preoperative anxiety, psychomotor functions, and soporific effect.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- compare the change of VAS-A score in melatonin, zopiclone, and alprazolam group on preoperative anxiety.
研究概览
简要总结
It is a Prospective, double-blind, randomized, comparative study.This study will be conducted to evaluate and compare the effect of melatonin, zopiclone, and alprazolam on preoperative anxiety, sedation, and psychomotor function in major elective surgeries
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I and II, Patients undergoing major elective surgeries of duration less than three hours.
排除标准
- •Surgery duration of more than three hours,
- •Myasthenia gravis,
- •Chronic intake of psychotropic drugs,
- •Severe obestructive sleep apnea,
- •Intracranial hypertension,
- •Morbid obesity,
- •Pregnant patients,
- •Patients unable to read or write basic alphabets, and
- •Re-do surgeries.
结局指标
主要结局
compare the change of VAS-A score in melatonin, zopiclone, and alprazolam group on preoperative anxiety.
时间窗: on the night before surgery before giving the drug , | and on the morning of surgery at 8:00 AM
次要结局
- compare the change of Digital Symbol Substitution Test in the melatonin, zopiclone, & alprazolam groups on preoperative & postoperative psychomotor functions.(in the morning before surgery at 8:00 am & five hours after the end of surgery.)
- compare the change of the four-point sedation scale between the melatonin, zopiclone, & alprazolam groups.(in the morning of surgery at 8:00 AM)
- To compare the level of sedation in patients receiving melatonin, zopiclone, & alprazolam.(on the morning of surgery)
研究者
研究点 (1)
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