A triple blinded randomised controlled trial on neurocognitive and psychomotor effects of melatonin versus midazolam when administered as preanaesthetic medication before surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Sedation
研究概览
简要总结
Anxiety before surgery occurs commonly and if untreated, can lead to intra and post operative hemodynamic issues due to sympathetic overdrive, as well as higher chances of infection and delayed wound healing. Hence pre operative anxiolytic medications have to be given. But all these anxiolytics have effects on the cognition and psychomotor function; which can be detrimental in daycare surgery,older patients and susceptible population. So in this study, we plan to study the effects of commonly used anxiolytics namely midazolam (oral and intranasal) and melatonin (oral and orobuccal) in standard doses and their effect on neurocognitive and psychomotor functions. The hypothesis being oral melatonin will have the least effects on neurocognitive and psychomotor functions when compared to midazolam in any route.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Adult Patients of ASA – PS classification I and II status between 18 – 60 years of age undergoing any surgery requiring anaesthesia, education high school and above.
排除标准
- •Patients with ASA – PS classification III physical status or greater, Patients less than 18 years of age and more than 60 years of age, Unwilling patients, patients with psychiatric disorders on anti psychotic drugs, language or communication difficulties, sleep disorders, renal or hepatic derangement, low intelligence quotient, abnormalities of the right and left hands and inability to read and write basic alphabets,obstetric.
结局指标
主要结局
Sedation
时间窗: baseline status checked, that is before drug administration and rechecked one hour after drug administration
Orientation
时间窗: baseline status checked, that is before drug administration and rechecked one hour after drug administration
Amnesia
时间窗: baseline status checked, that is before drug administration and rechecked one hour after drug administration
Cognitive and psychomotor dysfunction
时间窗: baseline status checked, that is before drug administration and rechecked one hour after drug administration
次要结局
- •Anxiolysis(•Adverse effects such as nausea, vomiting, hemodynamic disturbances etc)