- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03668951
Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children (DexPK)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Kristie Geisler, BS, CCRP
- Phone Number: 513-636-3282
- Email: kristie.geisler@cchmc.org
Study Contact Backup
- Name: Jayant Pratap, MA,MB BChir,MRCPCH,FRCA
- Phone Number: 513-803-3793
- Email: jayant.pratap@cchmc.org
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Joanna Paquin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
DEX 2 mcg/kg buccal
|
EXPERIMENTAL: 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.
|
DEX 3 mcg/kg intranasal
DEX 4 mcg/kg intranasal
|
EXPERIMENTAL: 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.
|
DEX 3 mcg/kg intranasal
DEX 4 mcg/kg intranasal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum blood concentration level of Dex - Cmax
Time Frame: 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).
|
Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
|
The amount of time that Dex is present at the maximum concentration - Tmax
Time Frame: 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.
|
Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve for Dex concentration levels
Time Frame: 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 samples.
|
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
Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
|
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM).
Investigators will be measuring for approximately one half-life of Dex.
This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex.
|
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.
Time Frame: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
|
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM).
Investigators will be measuring for approximately one half-life of Dex.
This will allow us to estimate the important clinical parameter of relative bioavailability of intranasal vs intravenous Dex.
|
Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
|
Adverse events associated with Dex administration
Time Frame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
|
Heart rate will be recorded by clinical staff prior to the procedure and continuously during the procedure.
The heart rate during the time of study blood collection will be compared to the baseline vitals to determine is any adverse events occurred.
|
Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
|
Systolic and diastolic blood pressure with Dex administration
Time Frame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
|
Systolic and diastolic blood pressure will be recorded by clinical staff prior to the procedure and continuously during the procedure.
The systolic and diastolic blood pressure during the time of study blood collection will be compared to the baseline blood pressure to determine is any adverse events occurred.
|
Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Heart Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 2018-3034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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