Prospective randomized controlled study for the management of delirium post- cardiac surgery: comparison of Quietapine Vs Melatonin
试验速览
- 阶段
- 2/3 期
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To observe the efficacy of Quietapine vs Melatonin in treatment of delirium post- cardiac surgery in the cardiac intensive care unit
研究概览
简要总结
Written informed consent will be obtained from the study population who will be eligible in terms of inclusion and exclusion criteria before participating in the study
Patient’s confidentiality will be maintained at all times and patients will be duly informed about the study
Preoperative cognition will be assessed Written and informed consent will be taken from the patient prior to the surgery Patient education, comorbidities like hypertension, diabetes, preoperative hemoglobin levels, EUROSCORE II will be noted
After extubation patient will be assessed by the confusion assessment method for the ICU CAM score
Patients with delirium will be randomized into 2 groups
Group Q Tab Quietapine 25 mg BD will be started
Group M Tab Melatonin 5 mg BD will be started
Patient will not be given any benzodiazepines during that period The CAM ICU score will be assessed every eighth hour during ICU stay and score will be noted for 7 days
Comparative analysis will be done whether delirium has decreased or not. Total duration of ICU stay of the patient will be noted
If patients delirium not improved then psychiatric reference will be done and treatment will be given accordingly
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All elective cardiac surgeries who developed delirium in ICU.
排除标准
- •Patient not on any antipsychotic medications No prior history of psychiatric illness No history of neurological disease or stroke / TIA No history of delirium prior to surgery.
结局指标
主要结局
To observe the efficacy of Quietapine vs Melatonin in treatment of delirium post- cardiac surgery in the cardiac intensive care unit
时间窗: baseline and every 8th hourly in ICU till post operative day 7
次要结局
- To observe length of ICU stay, postoperative complications & mortality & morbidity of patients(baseline & every 8th hourly in ICU till post operative day 7)
研究者
Dr Chanchal Bhandari
B.J. Medical College, Ahmedabad