Comparison of intravenous dexmedetomidine with local infiltration of ropivacaine in attenuation of stress response to skull pin insertion in craniotomies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of efficacy of intravenous dexmedetomidine in decreasing skull pin insertion response i.e. alteration in heart rate, mean arterial pressure, BIS, perfusion index,serum cortisol, serum prolactin& blood glucose.
研究概览
简要总结
The present prospective , randomized, comparative, double blind study will be conducted in the Department of Anaesthesiology and Critical Care, PGIMS, rohtak. Written informed and witnessed consent taken for participation. 18-65 years of patients of either sex belonging to ASA grade 2 or 3 undergoing elective craniotomy will be included. The patients will be divided in two groups one will receive intravenous dexmedetomidine other will recei8ve local infiltration of ropivacaine during skullpin insertion. Vitals and other parameters will be recorded at specified time interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade 1 to 3 undergoing elective craniotomy under general anaesthesia requiring application of head holder.
排除标准
- •bradycardia(<50) second or third degree heart block uncontrolled hypertention cardiac, renal or hepatic disease history of beta blocker intake glasgow coma scale <13 pitutary disease known allergic to local anaesthetic or dexmedetomidine.
结局指标
主要结局
Evaluation of efficacy of intravenous dexmedetomidine in decreasing skull pin insertion response i.e. alteration in heart rate, mean arterial pressure, BIS, perfusion index,serum cortisol, serum prolactin& blood glucose.
时间窗: Vitals are recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion . serum cortisol ,prolactin and blood sugar are measured baseline and 30 minutes after skullpin insertion.
次要结局
- systolic blood pressure, diastolic blood pressure, end tidal carbon dioxide level, SpO2, Fiso will be noted(Recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion)