A Partially Double-Blinded, Randomized, Controlled, Placebo-Controlled Study, a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Safety - Hemodynamic stability
研究概览
简要总结
This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH&RC standard of care. Compare the safety and the frequency of adverse effects of treatment arms.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital & Research Center (KFSH&RC) age 1-12 years
排除标准
- •Weight ≥ 40 kilograms
- •Allergies to the study drug
- •Refused to take the study drug
- •Severe learning disability
- •Patient on Digoxin medication
- •Patient on beta-blocker medication
- •Cardiac disease with abnormal conduction system
- •Nasal anatomical abnormality
研究组 & 干预措施
The sedative pre-medication oral Midazolam
干预措施: Midazolam (Drug)
The sedative pre-medication intranasal Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety - Hemodynamic stability
时间窗: 30 Minutes
The systolic and diastolic blood pressures will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Safety - Respiratory function
时间窗: 30 Minutes
The respiratory rate will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Anxiety Level
时间窗: 30 Minutes
Comparison of the level of anxiety as measured by The Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF) at the time when the child checks in at the front desk (say mYPAS-SF1), with when the attempt will be made to insert an IV line (say mYPAS-SF2). This scale is a score ranging from four (little anxiety) to twenty two (much anxiety).
Oxygen saturation
时间窗: 30 Minutes
The SpO2 will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
次要结局
- Visual Analog Scale for child anxiety(10 Minutes)
- IV cannulation procedure completion and number of attempts - yes or no(10 Minutes)
- Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects(60 Minutes)
- Post Hospitalization Behavior Questionnaire for Ambulatory Surgery(Day 2 post procedure)
- Likert scale assessment of how cooperative/easy to handle the child(10 Minutes)
研究者
Ganesh Sivasankara
Consultant, Anesthesiology
King Faisal Specialist Hospital & Research Center