Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum blood concentration level of Dex - Cmax
研究概览
简要总结
This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
详细描述
The study will be a prospective study of plasma concentrations after intranasal or buccal DEX to determine the early pharmacokinetics and bioavailability of a single dose via nasal or oral administration.
Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other pediatric institutions. This compound is typically delivered intravenously or intranasally for sedation in children with or without congenital heart disease. Intranasal DEX is very effective for sedation although it has significant variability in the onset and peak effect. Patient care will be improved if factors that determine this variability can be determined. Investigators will determine the important clinical variables of peak plasma DEX concentration (Tmax and Cmax) of intranasal and buccal DEX in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery
- •The subject must be a candidate to receive Dex as determined by one of the study cardiac anesthesiologists
- •The attending cardiac anesthesiologists for the case and the Chief of Anesthesia Cardiac Anesthesia will concur with or veto this decision
- •The subjects legally authorized representative has given written informed consent to participate in the study
排除标准
- •Post-natal age less than 6 months
- •The subject is allergic to or has had a contraindication to Dex
- •Severely depressed ventricular function on preoperative echocardiogram
- •The subject has a high risk of cardiac conduction system disease in the judgement of the attending anesthesiologist or cardiologist
- •The subject has a hemodynamically significant aortic coarctation or other left heart outflow obstruction
- •The subject has received digoxin, beta-adrenergic antagonist, or calcium channel antagonist on the day of surgery
- •The subject has received Dex within 1 week of the study date
- •Patients who are to receive intranasal Dex are excluded if they have nasal/respiratory symptoms, which in the opinion of the study anesthesiologist, may affect intranasal drug absorption
研究组 & 干预措施
Buccal DEX 2 mcg/kg
Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.
干预措施: Dexmedetomidine buccal (Drug)
Intranasal DEX 3 mcg/kg
Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.
干预措施: Dexmedetomidine Intranasal (Drug)
Intranasal DEX 4 mcg/kg
Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.
干预措施: Dexmedetomidine Intranasal (Drug)
结局指标
主要结局
Maximum blood concentration level of Dex - Cmax
时间窗: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
Dex concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax).
The amount of time that Dex is present at the maximum concentration - Tmax
时间窗: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
Dex concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts.
次要结局
- Adverse events associated with Dex administration(Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.)
- Area under the curve for Dex concentration levels(Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .)
- Bioavailability of intranasal Dex relative to intravenous Dex for distribution - plasma concentration(Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .)
- Bioavailability of IN Dex relative to intravenous Dex for elimination - plasma concentration.(Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .)
- Systolic and diastolic blood pressure with Dex administration(Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.)