To study comparative efficacy with three different doses of dexmeditomidine for prevention of etomidate induced myoclonus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Following Parameters will be statistically analysed:
研究概览
简要总结
This Prospective, Randomized, Double Blinded study will be conducted on 120 ASA I or II patients of age 18-60 years, posted for elective surgery under General Anesthesia in the Department of Anesthesia, DMCH, Ludhiana after ethical committee clearance. Patients will be randomly allocated to either of four groups as per computer generated random numbers. Group A will be given 10 ML of isotonic saline, whereas, Groups B, C, D will be administered Dexmedetomidine in a dose of 0.25 mcg/kg,0.5 mcg/kg and 1mcg/kg respectively in 10 ml of isotonic saline over 10 minutes .Once infusion is over, this time will be labelled as 0 and 0.3 mg/kg Etomidate will be given intravenously over 30 seconds. Patients will be observed for Myoclonus for 2 minutes which will be graded accordingly. Heart Rate, Blood Pressure, Hemoglobin saturation will be recorded after every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes. Incidence of adverse effects ( Hypotension , Bradycardia, Tachycardia, Hypertension) will be recorded.Results will be tabulated and statistically analysed.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I OR II with BMI <30 Kg/m2 and scheduled for elective surgery under general anaesthesia.
排除标准
- •Patients with BMI >30 kg/m2 .
- •Patients with Bradycardia (HR<60/min),Having Heart Blocks, on Beta Blockers or Having Impanted Pacemakers .
- •Known Case of Hypoadrenalism or Patients on Steroid medication .
- •H/o Asthma , Chronic Cough or Upper Respiratory Tract Infection Two weeks Prior to Surgery .
- •H/o any Neurological disease.
- •H/o any Psychiatric disease.
- •Pregnant and Lactating Patients.
- •H/o any Drug Allergy.
- •Patients having Uncontrolled Diabetes or Hypertension.
- •Patients who have received Benzodiazipines or Opioids within the previous 24 hrs.
- •Any evidence of Sepsis.
结局指标
主要结局
The Following Parameters will be statistically analysed:
时间窗: Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes.
1)Incidence of Etomidate
时间窗: Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes.
Induced Myoclonus.
时间窗: Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes.
2)Grading of Etomidate
时间窗: Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes.
3)Incidence of Any Adverse
时间窗: Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes.
Effects.
时间窗: Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes.
次要结局
- To find minimum effective dose of etomidate to suppress myoclonus(2 minute after induction)