An observational study to evaluate postoperative pain and neurocognitive decline in patients undergoing coronary artery bypass graft surgery with or without significant preoperative anxiety at SMS Medical College Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1) To assess and compare the postoperative visual analogue score in two groups
研究概览
简要总结
One day before operation patient will be made to fill APAIS (Amsterdam preoperative anxiety and information scale) questionnaire for anxiety and total anxiety score will be noted .
Weight, fasting status, written informed consent and pac will be checked.
Routine vital monitors attached ( ECG, spo2 , EtCO2). Peripheral IV line, ijv Central line, arterial line for invasive BP monitoring secured and vitals (SBP, DBP, MAP, CVP) will be noted.
After preoxygenation with 100% oxygen, induction will be done with injection midazolam 0.05 mg/kg ,injection fentanyl 4 microgram/ kg, injection etomidate 0. 3 mg per kg and injection rocuronium 0.9 mg/kg
After surgery in cardiac ICU study participants put on ventilator and extubated as per standard criteria.
Intravenous paracetamol 1 g and injection tramadol 1 mg/ kg will be given 8 hourly.
When visual analog score exceed 4 , injection fentanyl 1 microgram per kg will be given.
Collection of data
Visual analogue score determined at 15 minutes after excavation and then 3 hr, 6, 12 ,18, 24, 30, 36, 42 ,48 hours postoperatively.
Total dose of fentanyl given within 48 hours after extubation .
Neurocognitive function by mini mental State examination ( MMSE) on post of day 1,2,3,4
Hemo dynamic parameter (mean arterial pressure ,heart rate) determined post operatively at 30 minute 1 hour 3 , 6 ,12, 18, 24 ,30, 36, 42, 48 hour
Duration of ICU stay in days.
Statistical analysis ( all data will be entered into a soft Excel spreadsheet and will be analyzed statistically using appropriate tests and software)
Conclusion
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients giving informed written consent.
- •Aged between 18 to 65 years
- •Patients with ASA grade class II to III undergoing elective coronary artery bypass graft surgery.
排除标准
- •Patients who had undergone prior cardiothoracic procedure.
- •Participants giving history of opioid addiction.
- •Patients with other comorbidities.
- •Patients with any type of psychiatric illness or delirium before surgery.
- •5.Patients taking part in any other study.
结局指标
主要结局
1) To assess and compare the postoperative visual analogue score in two groups
时间窗: 1) To assess the visual analogue score at 15 minutes and then 3,6,12, 18, 24, 30, 36, 42, 48 hours after extubation | 2) To determine total dose of fentanyl within 48 hours after extubation. | 3) To assess the neuro cognitive function by mini mental State examination on post op day 1, 2, 3 and 4.
2) To determine the difference in the consumption of fentanyl post operatively between the two groups
时间窗: 1) To assess the visual analogue score at 15 minutes and then 3,6,12, 18, 24, 30, 36, 42, 48 hours after extubation | 2) To determine total dose of fentanyl within 48 hours after extubation. | 3) To assess the neuro cognitive function by mini mental State examination on post op day 1, 2, 3 and 4.
3) To assess and compare the neuro cognitive function between the two groups
时间窗: 1) To assess the visual analogue score at 15 minutes and then 3,6,12, 18, 24, 30, 36, 42, 48 hours after extubation | 2) To determine total dose of fentanyl within 48 hours after extubation. | 3) To assess the neuro cognitive function by mini mental State examination on post op day 1, 2, 3 and 4.
次要结局
- 1)To assess and compare the hemodynamic parameters between the two groups.(2)To determine the duration of ICU stay in days.)
研究者
Dr Reema Meena
Sawai Man Singh Medical College,Jaipur