A prospective, double blinded randomized study to evaluate and compare nebulized fentanyl, dexmedetomedine and magnesium sulphate for attenuation of haemodynamic stress response to laryngoscopy and intubation
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate attenuation of haemodynamic response to laryngoscopy and intubation
研究概览
简要总结
direct laryngoscopy and intubation result in pressor response which is associated with increase in heart rate and blood pressure due to stimulation of sympathetic system. it can cause serious complications in patients of coronary artery disease, raised icp etcmany studies compare intravenous form we will compare nebulised dexmedetomedine, magnesium sulphate and fentanyl for attenuation of haemodynamic response to laryngoscopy and intubation
primary objective to evaluate pressoer response. secondary outcome to record any side effects
this prospective .double blinded randomised study will be conducted in esic faridabad with above stated inclusion and exclusion criteria
statistical test anova with post hoc bonferroni correction for quantitative and chi square for qualitative data
preanaesthetic evaluation will be done. pt kept fasting by asa guidelines
informed written consent to be taken. randomisation with envelope method into 3 groups
preop vitals - heart rate. systolic bp , diastolic bp ,mean arterial pressure recorded
group a : nebilsation with fentanyl 1mcg/kg in normal saline total 5 ml @ o2 6l/m before induction
group b:nebulisation with dexmedetomedine 1mcg/kg
group c: nebulisation with magnesium sulphate 40mg/kg max up to 2g
after neb pt taken in ot and hr.sbp.dbp.map recorded
preoxygenation done. premedication with inj fentanyl 2mcg/kg iv, induction with propofol 2mg/kg iv check ventilation vec 0.08mg/kg iv 3min ippv followed by dl scopy and intubation
2 min . 5 min and 10 min after intubation hr. sbp.dbp.map will be recordedno stimulus allowed during study period
fall in map>20% treated with inj ephedfrine 6mg iv and hr <45/min treated by atropin 0.6 mg iv
no ethical implications as these drugs are routinely used in anaesthesia practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor 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
- •Patients between age of 18 and 60 yrs ASA grade 1 and 2 Patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation Mallampati grading I to II.
排除标准
- •Patient refusal Drug allergy Patient with apparent difficult airway Patients in ASA grade III & above Patients who require Intubation time > 20 sec Patients having BMI>30 Pregnancy.
结局指标
主要结局
To evaluate attenuation of haemodynamic response to laryngoscopy and intubation
时间窗: baseline reading, after nebulisation, 2min, 5min, 10 min after intubation
次要结局
- adverse effect in any(2 min 5 min 10 min after intubation)