Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 322
- 主要终点
- Change of Anxiety in children
研究概览
简要总结
This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children from ages 4 years to 8 years old undergoing outpatient surgery
- •children identified as needing premedication
- •ASA physical status I, II or III
- •planned inhalational induction
- •children presenting from home prior to surgery (not an inpatient)
- •English speaking parents and child
排除标准
- •children with developmental delay
- •children with psychological / emotional disorders
- •children with altered mental status
- •children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
- •children with language barrier
- •children who are not accompanied by someone able to consent (ie legal guardian)
- •children who are inpatient prior to surgery
- •children with expected difficult intubation/airway
- •children presenting for emergency surgery
- •family history or personal history of malignant hyperthermia / risk of MH
- •consent not obtained or withdrawal of consent
- •children with past history of violent behaviors during induction of anesthesia
- •cancellation of surgery
- •patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precautions in the operating room
- •receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.
研究组 & 干预措施
Virtual Parental Presence on Induction of Anesthesia group
Use of Facetime with child and parents during induction
干预措施: Virtual Parental Presence on Induction of Anesthesia (Behavioral)
Midazolam Group
0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively.
干预措施: Midazolam (Behavioral)
结局指标
主要结局
Change of Anxiety in children
时间窗: baseline, immediately after the intervention
We will be using the modified Yale Preoperative Anxiety Scale (mYPAS) which was developed specifically to measure anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults. It has a good validity against the State-Trait Anxiety Inventory for Children, as well as good intra and inter-observer reliability. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety.
次要结局
- Induction compliance(immediately during anesthetic induction)
- Change of parental anxiety(baseline, immediately after anesthetic induction)
研究者
Thomas Caruso
Clinical Professor
Stanford University