Correlation of sedation depth assessed by the ramsay sedation scale and bispectral index using intravenous dexmedetomidine or propofol in patients undergoing spinal anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation of sedation depth achieved by both IV drugs
研究概览
简要总结
Our primary aim is To assess the correlation between the Ramsay Sedation Scale (RSS) scores and Bispectral Index (BIS) values in patients sedated with dexmedetomidine or propofol during spinal anaesthesia.
Our secondary aim is To evaluate the hemodynamic changes associated with the use of dexmedetomidine and propofol and To assess the recovory profile and side effects associated with each sedative agent with hemodynamic stability.
60 patient undergoing below umbilical surgery randomly selected according to inclusion and exclusion criteria and randomly allocated in group P (propofol group) and Group D (dexmedetomidine). all patient given sedation according to dosage and sedation depth, hemodynamic stability, patient and surgeon satisfaction assessed,
We propose that, where there is lack of instrumentation and expertise for BIS score assessment, the RSS score could be used to map the level of sedation. We propose that the RSS should be used to monitor depth in all patients requiring sedation under spinal anaesthesia with accuracy similar to that of the BIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Group 18 years to 50 years ASA I and II.
排除标准
- •Patient refusal Patient with local infections of back and spine Patient having vertebral column anomalies Patient with bleeding disorders Patient with obstructive sleep apnea Patient having hypertension morbid obesity severe hepatic renal endocrinal(DM) neurological disorders Psychiatric drug history gastrointestinal and cardiac dysfunction.
- •History of allergy to drug understudy Patient with ACE inhibitors alpha 2 adrenergic receptors antagonists beta blockers calcium channel blockers.
结局指标
主要结局
Correlation of sedation depth achieved by both IV drugs
时间窗: Till 90 mins
次要结局
- Hemodynamic Stability(Adverse effect if any)
研究者
Ashish Bhatiya
Government Medical College Baroda