The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Anxiety during induction
研究概览
简要总结
This project will investigate whether reduction in ambient light and elimination of noise on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic premedication. In addition, the investigators will assess the cumulative level of nose exposure that patients experience during the perioperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing general anesthesia for tonsillectomy/adenoidectomy, tympanomastoidectomy, or general abdominal laparoscopic surgical procedures lasting at least 30 minutes.
- •Receiving midazolam prior to the procedure as part of standard of care.
排除标准
- •Patients that are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs.
- •Allergy to midazolam.
- •History of emergence delirium.
- •Cardiac disease, other than functional heart murmurs.
- •Developmental delays.
- •Parent refusal of midazolam for standard clinical care.
结局指标
主要结局
Anxiety during induction
时间窗: First 5 minutes of surgical procedure
A blinded observer will assess behavior prior to and during induction/placement of face mask or insertion of an intravenous line using the mYPAS scale.
次要结局
- Noise exposure(Average of 30 mins - 3 hrs)
- Compliance during induction(First 5 minutes of surgical procedure)
- Presence of post anesthesia emergence delirium(Average of 30 mins - 1 hr)
- Post-discharge behavior disturbances(Post-op day 7)
研究者
Joshua Uffman
Vice Chair, Department of Anesthesiology & Pain Medicine
Nationwide Children's Hospital