To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laryngoscopy and Intubation in Patients Undergoung Elective Intubation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- heart rate will be recorded at 0,1,5,10 min after laryngoscopy and intubation
研究概览
简要总结
Laryngoscopy and intubation are painful stimuli ,that results in adverse physiological outcomes,like tachycrdia ,hypertension,arrythmiaa,pulmonary edema.
The main objective of study is to blunt the autonomic response of laryngoscopy and intubation.
Title of the study :To evaluate the effect of dexmedetimedine nebulization upon blunting autonomic response of laryngoscopy and intubation in patients undergoing elective intubation.
It is randomized control trial,sample size was calculated by using openEpi sample size calculator By using SBPafter 1 min of laeyngoscopy in decmedetomedine versus group were 113.2+_14.503and 125.92+_15.263 respectively,power 95 percent and confidence 95 percent ,The required sample size for the study is 72( 36 ) in each group.
After taking informed consent patients are randomly divided into two groups via opaque sealed envelop technique.Half of envelops will be labelled as letter D ,and half will be labelled as letter C .Patients in group D will be nebulized with dexmedetomedine with dose of 1ug/kg made total volume of 5 ml with normal saline.While group C will be nebulized with 5 ml of 0.9 percent normal saline 30 min prior to elective intubation.Hemodynamic parmmeters heart rate ,systolic bp,diastolic bp,MAP will be noted at baseline and 0,1,5,10 min after inrubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years ASAI-III Both genders Patients undergoing elective intubation
排除标准
- •Patients with renal hepatic or neurological disease Bleeding diathesis Mallampatti III-IV Previous histoey of difficult intubation.
研究组 & 干预措施
Dexmedetomedine nebulization in group D
Dexmedetomedine nebulization done with a dose of1ug /kg 30min prioor to induction of general anaesthesia
干预措施: Nebulization of dexmedetomedine in group D (Drug)
Normal saline nebulization in group C
Normal saline nebulization done 30min prior to induction of general anaesthesia,hemdynamic parameters heart rate,systolic bp,diastolic bp,MAP,will be noted at baseline,0,1,5,10 min after intubation
干预措施: Nebulizition with normal saline in group C,after taking informed consent patients in group cwill be nebulized with 5 ml of normal saline 30 min prior to elective intubation ,HR,SBP,DBP,MAP monitored. (Drug)
结局指标
主要结局
heart rate will be recorded at 0,1,5,10 min after laryngoscopy and intubation
时间窗: Heart rate will be monitired at base line,0min,1min,5min,10min after intervention
SBP,DBP,MAP. measurement will be required at o ,1,5,10 min after laryngoscopy and intubation.
时间窗: SBP,DBP,MAP, will be recorded at 0,1,5,10 min after laryngoscopy and intubation
次要结局
未报告次要终点
研究者
Hafiza Javeria Jawed
Principal investigator
Dow University of Health Sciences