Comparison of parental presence with oral midazolam premedication for reducing preoperative anxiety in children undergoing elective surgery under general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Anxiety score measured by Modified Yale preoperative anxiety scale Score (mYPAS)
研究概览
简要总结
Randomized Comparative Study will be conducted in the Department of Anaesthesia, ABVIMS & Dr. Ram Manohar Lohia Hospital, New Delhi- 110001 after the Institutional Ethics Committee Approval. Written informed consent from patient’s parents will be taken. The study will include patients, undergoing elective surgical procedures under General Anaesthesia.
Sample size = 80
Primary objective is to compare parental presence with oral midazolam premedication for reducing preoperative anxiety in children undergoing elective surgery under general anaesthesia.
Secondary objective is to compare the face mask acceptance score at the time of induction between the two groups and compare the hemodynamic parameters starting from preoperative period to face mask application for induction in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society of Anaesthesiologists [ASA] physical status I and II patients.
- •Elective surgical procedure.
排除标准
- •Difficult airway
- •Mental or physical disabilities
- •Treatment with sedatives or anticonvulsant.
结局指标
主要结局
Anxiety score measured by Modified Yale preoperative anxiety scale Score (mYPAS)
时间窗: mYPAS will be measured at 3 points : | 1.just before shifting to OT 2.placing patient on OT table 3.On introduction of face mask during induction of anaesthesia.
次要结局
- Face Mask acceptance score by Mask acceptance scale (MAS)(Hemodynamic parameters (HR, SpO2) in both groups)
研究者
Averine Paulose
ABVIMS AND DR RML HOSPITAL NEW DELHI-110001