Comparison of effects of nebulised midazolam versus nebulised fentanyl as a premedication in the age group of 2 to 8 years of children undergoing general Aneasthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary objective- to evaluate.
研究概览
简要总结
Comparing the effects of nevbullised midazolam vs nebulised fentanyl as a premedication in 2 to 8 years of children undergoing the general anesthesia. As children’s are more afraid of invasive procedure and hospital environment, we emphasise on the smooth parental separation and preparation of child’s for the surgery which won’t cause traumatic experience to child.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of age group 2 to 8 years with physical status American Association of Anesthesiology (ASA) Class I and Class II.
- •Children belonging to either sex.
- •Children not having a history of: a.
- •Upper airway disease b.
- •CNS dysfunction
- •No Allergy to the drugs under study
- •Children’s undergoing general anesthesia
- •All children with guardian/parents who give consent to take the premedication.
- •Patients with no intranasal pathology or children with airway congenital anomaly.
排除标准
- •Children physical status American Association of Anesthesiology (ASA) Class III and Class IV
- •Children with pre-existing cardiovascular, renal, and hepatic disorders, Diabetes mellitus
- •Children known to have allergic reaction to opioids drugs.
- •Children allergic to either of study drugs b.
- •Patients with any intranasal pathology or children with any congenital anomaly.
- •Children refused to take the premedication due to any reasons.
结局指标
主要结局
Primary objective- to evaluate.
时间窗: Primary objective- to evaluate. | i. Onset and Duration of Sedation. | ii. Acceptance of Mask and Other Non-Invasive Maneuver. | iii. Onset of Decrease of the Stress Response. | Secondary objective- to evaluate. | i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation) |  
i. Onset and Duration of Sedation.
时间窗: Primary objective- to evaluate. | i. Onset and Duration of Sedation. | ii. Acceptance of Mask and Other Non-Invasive Maneuver. | iii. Onset of Decrease of the Stress Response. | Secondary objective- to evaluate. | i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation) |  
ii. Acceptance of Mask and Other Non-Invasive Maneuver.
时间窗: Primary objective- to evaluate. | i. Onset and Duration of Sedation. | ii. Acceptance of Mask and Other Non-Invasive Maneuver. | iii. Onset of Decrease of the Stress Response. | Secondary objective- to evaluate. | i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation) |  
iii. Onset of Decrease of the Stress Response.
时间窗: Primary objective- to evaluate. | i. Onset and Duration of Sedation. | ii. Acceptance of Mask and Other Non-Invasive Maneuver. | iii. Onset of Decrease of the Stress Response. | Secondary objective- to evaluate. | i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation) |  
次要结局
- Secondary objective- to evaluate.(i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation))
研究者
Dr Poornima Sonkamble
Department of Aneasthesia