Comparative Study Between Intranasal and Intravenous Dexmedetomidine As A Premedication To Attenuate Hemodynamic Response To Laryngoscopy And Endotracheal Intubation In Elective Lumbar Spine Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean arterial pressure (MAP)
研究概览
简要总结
**1.**Laryngoscopy andtracheal intubation violate the patient’s airway reflexes and predictably leadto hypertention and tachecardia.Dexmedetomidine is a potent, highly selectiveand specific alpha2 agonist that has both sedative and analgesic effects withminimal respiratory depression. Various methods of drug delivery areoral,rectal, intravenous, intramuscular ,but intranasal route is advantageousin that it is easy to use, painless, odourless,tasteless, well tolerated,avoids first pass metabolism with more haemodynamic stability1
**2.****Methodology:**A prospective randomized doubleblind study will be carried out on 70( ASA-1andII)patients, aged 18-60years,scheduled for elective lumbar spine surgery under generalanaesthesia.Group -DIN,patients will receive intranasaldexmedetomidine1 mcg/kg andGroupDI.V willreceive intravenous Dexmedetomidine at0.75µg/kg before induction.Hemodynamic response will be monitored in every 10 min intervalsfrom drug administration to induction, immediatelyafter intubation, then every 1 min interval till 5mins and at 7 min and 10 min afterintubation.
**3.****Expected outcome :**The primary expectedoutcome from the study that whether the effect of intranasal Dexmedetomidine is superior,equivalent orinferior to that of intravenous Dexmedetomidine during laryngoscopy andintubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator 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 with ASA physical status I and II.
- •Patients having Mallampati I and II 3)Patients in the age group between 18 to 60 years of age 4)Patients with body mass index (BMI) < 30 kg/m2 5)Patients of either sex 6)Patients posted for elective lumber spine surgery under general anaesthesia.
排除标准
- •Patients refusal to participate in the study 2)Known allergy or hypersensitive reaction to dexmedetommidine.
- •Patients suffering from significant cardiac disease e.g. IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc.
- •Patients suffering from significant respiratory disease e.g. COPD, bronchial asthma, interstitial lung diseases, pneumonia etc.
- •â€¢Patients having metabolic, endocrinal, musculoskeletal, neurologic disorder or having major congenital anomalies.
- •â€¢History of drug abuse and/or psychiatric disorder.
结局指标
主要结局
Mean arterial pressure (MAP)
时间窗: Mean arterial pressure (MAP) at baseline then every 10 min intervals from intranasal dexmedetomidine administration in preinduction period, during induction, after intubation, every 1 min interval till 5mins and at 7 min and 10 min after intubation.
次要结局
- heart rate (HR), , respiratory rate (RR) and oxygen saturation (spO2)(Baseline sedation status will be assessed by an observer using theRamsay sedation scale)