EVALUATE OF HAEMODYNAMIC RESPONSE OF INTRAVENOUS NALBUPHINE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION IN SURGERIES OF EAR NOSE THORAT (ENT) DONE UNDER GENERAL ANAESTHESIA
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Nalbuphine IV (150mcg/kg) injected before induction of elective surgeries in ENT to be done under general anaesthesia will effectively attenuate the hemodynamic stress response of orotracheal intubation
研究概览
简要总结
Endotracheal Laryngoscopy are crucial concerns in geeneral anaesthesia and can lead to life threatening changes.Intravenous Nalbuphine attenuates such hemodynamic changes.Study aims to assess the effectiveness of intravenous nalbuphine in reducing anxiety during intubation in ENT surgeries under general anaesthesia.One group will recieve nalbuphine intravenously and a control group wil recieve saline.Hemodynamic parameters will be measured at different times.The nalbuphine group is expected to have a significantly reduced magnitude of hemodunamic response as compared to the placebo group.Also,nalbuphine is expected to have a good safety profile with no significant adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of elective ENT procedures under GA.
- •Patients weighing between 40 to 80kg.
- •Patients belonging to ASA grade I and II.
- •Patients with anticipated difficult airways according to LEMON criteria.
排除标准
- •Patients with known drug allergy.
- •Patients of emergency surgeries.
- •Patients belonging to ASA grade III or higher.
- •Patients with uncontrolled systemic disease.
- •Pregnant or lactating females.
结局指标
主要结局
Nalbuphine IV (150mcg/kg) injected before induction of elective surgeries in ENT to be done under general anaesthesia will effectively attenuate the hemodynamic stress response of orotracheal intubation
时间窗: T0-Baseline premedication vitals,T1-3 minutes after administration of Nalbuphine,T2-1 minute after induction and intubation,T3-3 minutes after intubatin,T4-5 minutes after intubation,T5-10 minutes after intubation.
次要结局
未报告次要终点
研究者
Dhruv Shah
Datta Meghe Institute of Higher Education and Research