CTRI/2025/07/091710尚未招募不适用
A Randomized Single Blinded Study Comparing the Effects Of Oral Melatonin with Oral Alprazolam used as Premedication in Adult Patients Undergoing Surgery Under General Anaesthesia
Dr Avinash K1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare effect of premedication with melatonin and alprazolam on preoperative anxiety,sedation,orientation and cognitive function.
研究概览
简要总结
Preoperative Anxiety is a common thing among patients posted for surgery. To allay the fears of the patient prior to surgery ,premedication is given to the patient. In our study we are comparing the effects of one commonly used drug for premedication like Alprazolam and the other drug melatonin. The effects of Melatonin as premedication drug is not fully understood , Hence this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society Of Anaesthesiologists Grade I-II
- •Posted for Surgery greater than One Hour Under General Anaesthesia.
- •Patients giving Valid and Informed Consent.
排除标准
- •1.Patients with ASA physical status classes 3 and above.
- •2.Age greater than 60 years or less than 18 years.
- •3.Patients having allergy to any of the study drugs 4.Pregnant women 5.Patients with any mental illness.
- •6.Patients on steroids and antipsychotics.
- •7.Patients unable to read or write basic alphabets.
- •8.Patients with uncontrolled hypertension and diabetes 9.Patient refusal.
结局指标
主要结局
To compare effect of premedication with melatonin and alprazolam on preoperative anxiety,sedation,orientation and cognitive function.
时间窗: 0min and 120 min
次要结局
未报告次要终点
研究者
Dr Avinash K
KLE Jagadguru Gangadhar Mahaswamigalu Moorsavirmath Medical College
研究点 (1)
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