Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Measurement of base of tongue under anesthesia
研究概览
简要总结
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults.
The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.
详细描述
Upper airway obstruction is a common problem in spontaneously breathing patients under anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on the muscle tone and airway configuration in children under anesthesia. The hypothesis is adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology when compared to previously collected data using dexmedetomidine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine
- •Patient must be 1 to 18 years of age
- •Patients legally authorized representative has given written informed consent to participate in the study
排除标准
- •Allergy to dexmedetomidine or ketamine
- •History or obstructive sleep apnea
- •The patient has a life-threatening medical condition (ASA status 4, 5, or 6)
- •The patient is not scheduled to receive anesthesia sedation for the MRI
- •Patient has a history or a family history of malignant hyperthermia
研究组 & 干预措施
Anesthesia for MRI
All patients will receive the same drugs.
A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken.
干预措施: Dexmedetomidine (Drug)
Anesthesia for MRI
All patients will receive the same drugs.
A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken.
干预措施: Ketamine (Drug)
结局指标
主要结局
Measurement of base of tongue under anesthesia
时间窗: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
Measurement of soft palate under anesthesia
时间窗: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan
次要结局
- Anteroposterior dimension and transverse dimension of base of tongue(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)
- Heart rate relative to baseline before dexmedetomidine is given(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)
- Anteroposterior dimension and transverse dimension of soft palate(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)
- Episodes of low oxygen saturation(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)
- Placement of adjunct airway(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)
- Patient movement during MRI(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)
- Arterial blood pressure relative to baseline before dexmedetomidine is given(Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes)