Effect of dexmedetomidine as an adjunct to lorazepam for alcohol withdrawal syndrome in icu: a prospective randomized controlled double blinded study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparing delirium free days in intervention group and control group.
研究概览
简要总结
This study is a randomized , double blind , parallel group , single center trial comparing the effectiveness of lorazepam and dexmedetomidine infusion versus lorazepam alone in patients with alcohol withdrawal symptoms in intensive care unit and this study will be conducted in critical care Department.The primary outcome will be delirium free days in first 7 days of admission in each group and secondary outcome will be comparison between two groups with respect to the number of patients achieving a significant reduction in mMINDS after 48 hours ,length of ICU stay (in days),ventilator free days, incidences of rescue sedation in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients admitted in ICU with medical or surgical illness with features of alcohol withdrawal syndrome or alcohol withdrawal delirium as per DSM V definition at the time of ICU admission.
排除标准
- •Active status epilepticus,Pregnancy or lactation,Known allergy or adverse response to any of the study medications,Severe hepatic impairment (Child Pugh C ),Serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia),Heart rate less than 50 per min,Second- or third degree heart block,Systolic blood pressure less than 90 mm Hg despite continuous infusions of more than o.8microgram per hour infusion of noradrenaline before allocation to study group,Previous randomization into this study,those who are not expected to stay in ICU for less than 48 hours.
结局指标
主要结局
Comparing delirium free days in intervention group and control group.
时间窗: Delirium free days - 7 days
次要结局
- Comparing mMINDS score,(comparing length of ICU stay ( in days),comparing ventilator free days,comparing the use of additional sedatives to achieve RASS 0 to -2)
研究者
Nimisha George
Jubilee mission medical college and research institute