Incidence of Delirium with Dexmedetomidine compared with fentanyl based therapy in post operative cardiac surgical patients:A Randomized controlled single blinded study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To compare the incidence of postopertive delirium(confusion assessment method)with dexmedetomidine and fentanyl
研究概览
简要总结
This is a prospective randomised single blinded comparative study conducted at our institution in CTVS operation theatre and ICU •The data to be collected are all part of routine care. •All the Data collected will be entered in Microsoft excel 2007 and further analysed in SPSS VERSION-27.Categorised variables will be expressed in numericals and percentage.Continuous variable will be expressed by CHI-SQUARE/FISCHER EXCAT TEST.Comparision between two means will be assessed using T test/Mann whitney. •P value <0.05 will be constant • SAMPLE SIZE •Assumption :150 •Method Used:Based on previous study of yahya shehabi,the incidence of delirium in F group is 28%.To detect clinically relevant 50% reduction in delirium in DEXMEDETOMIDINE group with alpha value of 0.05 power of 80% and with 1:1 Randomization the sample size was calculated to be 150(75 in each group).The sample size was calculated in spss version 27 after considering no drop out. •Initial estimate :150 •Corrected estimate :150
In this study 150 cardiac patients between age 18 years to 80 years posted for elective on pump cardiac surgery were included
After taking written informed consent from parents/guardians, patients will be randomized to 2 groups (n= 75 each ) by computer generated random number table. All patients will be thoroughly examined pre-operatively which includes blood pressure, heart rate, respiratory rate and systemic examination, and ASA grading. The patients with a contraindication to procedure like allergic reaction to opioids or major neurological, cardiovascular, metabolic, respiratory, renal disease, or coagulation abnormalities and liver dysfunction will be excluded.
The confusion assessment method scale for delirium severity will be explained to all the patients.
The sedation is assessed by Richmond Agitation and sedation scale and it has a scale from -4 to +5 together with pain scale critical-care pain observation toll(CPOT) and Wong-Baker Faces Pain will be explained to all the patients.
CAM-SCALE consists of 4 items with 0-2 grades, they are Acute onset or fluctuation of mental status,Inattention,Altered level of consciousness and Disorganized thinking.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of age group 18-80 years scheduled for on pump cardiac surgeries.
排除标准
- •1.Patients not giving consent 2.Patients with severe congestive heart failure,(ejection fraction less than 40),second degree heart blocks,neurological disorders,renal and liver failures.
- •3.If patient is hypotensive preoperatively.
- •4.If patient baseline heart rate is less than 55per min.
- •5.If patient has pacemaker insitu.
- •6.Patient getting reoperated.
- •7.Patient hypersensitive to opioids and known drug allergies.
结局指标
主要结局
To compare the incidence of postopertive delirium(confusion assessment method)with dexmedetomidine and fentanyl
时间窗: 12th hourly for 7 days.
次要结局
- Duration of sedation and analgesia,trail of extubation done after 12 hours of shifting the patient to ICU, ,incidence of tachyarrythmias,haemodynamic parameters(HR,MAP,SPO2) and side effects like nausea and vomitings(2,,6,12,24,48 hourly-sedation and analgesia)
研究者
Pavani paidi
Institue of medical science and sum hospital.