Heart DiseasePhase 1NCT02836431
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
A Phase 1 study testing Dexmedetomidine 1mcg/kg Intranasal, Dexmedetomidine 2mcg/kg Intranasal and Dexmedetomidine 1mcg Intravenous in people with Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX. Read more about this study
- Who is it for?
- Ages 6 to 48 months
- Conditions the study is for
- Heart Disease
- What is being tested?
- Dexmedetomidine 1mcg/kg Intranasal, Dexmedetomidine 2mcg/kg Intranasal and Dexmedetomidine 1mcg Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery.
- The subject must be a candidate to receive DEX. A physician member of the Division of Cardiac Anesthesiology, not involved in the study, will make this decision.
- The subject's legally authorized representative has given written informed consent to participate in the study.
Who cannot join
- Post-natal age (PNA) < 6 months
- The subject is allergic to or has a contraindication to DEX
- Severely depressed ventricular function (ejection fraction 30% or less) on preoperative echocardiogram
- The subject has high risk cardiac conduction system disease at the discretion of the attending anesthesiologist or cardiologist.
- The subject has a hemodynamically significant coarctation or other left heart outflow obstruction
- The subject has received digoxin, beta-adrenergic antagonist, or calcium-channel antagonist on the day of the study
- The subject has received DEX within 1 week of the study date (information obtained from: parent or Medical record)
- Subject have nasal/respiratory symptoms which in the opinion of the Principal investigator, may affect intranasal drug absorption.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
Read the detailed description
The study will be a prospective study of plasma concentrations after intranasal (1 µg/kg and 2µg/kg) and intravenous (1 µg /kg) DEX to determine the early pharmacokinetics (maximum concentration (peak) and time to peak) and bioavailability of a single intranasal dose in pediatric patients.
Dexmedetomidine sedation is commonly utilized at Cincinnati Children's Medical Center (CCHMC) and other pediatric institutions. This compound is delivered intravenously or intranasally for sedation in children with and without congenital heart disease. Intranasal DEX, though very effective for sedation, has significant variability in its onset and peak effect. Patient care will be significantly improved if factors that determine this variability in onset and peak effect can be determined. Investigators will determine the important early clinical variables of peak plasma DEX concentration (Tmax and Cmax) and the 0 - 2 hour bioavailability of intranasal DEX in children.
- Conditions
- Heart Disease
- Being tested
- Dexmedetomidine 1mcg/kg Intranasal, Dexmedetomidine 2mcg/kg Intranasal, Dexmedetomidine 1mcg Intravenous
- Keywords
- Pediatric, Sedation, Dexmedetomidine
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 1mcg/kg IntranasalDrug
DEX 1 mcg/kg Intranasal
Dexmedetomidine 2mcg/kg IntranasalDrug
DEX 2 mcg/kg Intranasal
Dexmedetomidine 1mcg IntravenousDrug
DEX 1 mcg/kg Intravenously
| Study group | Role | What they receive |
|---|---|---|
| DEX 1 mcg/kg Intranasal | Experimental | 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. Receives: Drug: Dexmedetomidine 1mcg/kg Intranasal |
| DEX 2 mcg/kg Intranasal | Experimental | 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. Receives: Drug: Dexmedetomidine 2mcg/kg Intranasal |
| DEX 1 mcg/kg Intravenous | Experimental | 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. Receives: Drug: Dexmedetomidine 1mcg Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum blood concentration level of DEX - Cmax
DEX concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
Measured: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
The amount of time that a DEX is present at the maximum concentration - Tmax
DEX concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts (Tmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
Measured: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Area under the curve for DEX concentration levels
DEX concentration will be measured in the blood samples. Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
Measured: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Bioavailability of intranasal DEX relative to intravenous DEX for distribution - plasma concentration
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring distribution for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.
Measured: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Bioavailability of intranasal DEX relative to intravenous DEX for elimination - plasma concentration
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring elimination for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.
Measured: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Secondary outcomes (1)
Adverse events associated with DEX administration
Heart rate and blood pressure are recorded by clinical staff prior to the procedure and continuously during the procedure. The heart rate and blood pressure during the time of study blood collection will be compared to the baseline vitals to determine if any adverse events occurred.
Measured: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Miller, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836431
- Sponsor's protocol ID
- 2015-5966
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
- ClinicalTrials.gov ID
- NCT02836431
- Acronym / sponsor ID
- 2015-5966
- Conditions
- Heart Disease
- Keywords
- Pediatric, Sedation, Dexmedetomidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
Detailed description
The study will be a prospective study of plasma concentrations after intranasal (1 µg/kg and 2µg/kg) and intravenous (1 µg /kg) DEX to determine the early pharmacokinetics (maximum concentration (peak) and time to peak) and bioavailability of a single intranasal dose in pediatric patients.
Dexmedetomidine sedation is commonly utilized at Cincinnati Children's Medical Center (CCHMC) and other pediatric institutions. This compound is delivered intravenously or intranasally for sedation in children with and without congenital heart disease. Intranasal DEX, though very effective for sedation, has significant variability in its onset and peak effect. Patient care will be significantly improved if factors that determine this variability in onset and peak effect can be determined. Investigators will determine the important early clinical variables of peak plasma DEX concentration (Tmax and Cmax) and the 0 - 2 hour bioavailability of intranasal DEX in children.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DEX 1 mcg/kg Intranasal | Experimental | Drug: Dexmedetomidine 1mcg/kg IntranasalStandard 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 Intranasal | Experimental | Drug: Dexmedetomidine 2mcg/kg IntranasalStandard 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 1 mcg/kg Intravenous | Experimental | Drug: Dexmedetomidine 1mcg IntravenousStandard 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. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 - 48 months (inclusive) scheduled to receive anesthesia for elective cardiac surgery.
- The subject must be a candidate to receive DEX. A physician member of the Division of Cardiac Anesthesiology, not involved in the study, will make this decision.
- The subject's legally authorized representative has given written informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Post-natal age (PNA) < 6 months
- The subject is allergic to or has a contraindication to DEX
- Severely depressed ventricular function (ejection fraction 30% or less) on preoperative echocardiogram
- The subject has high risk cardiac conduction system disease at the discretion of the attending anesthesiologist or cardiologist.
- The subject has a hemodynamically significant coarctation or other left heart outflow obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine 1mcg/kg IntranasalDEX 1 mcg/kg Intranasal | Drug | DEX 1 mcg/kg Intranasal |
| Dexmedetomidine 2mcg/kg IntranasalDEX 2 mcg/kg Intranasal | Drug | DEX 2 mcg/kg Intranasal |
| Dexmedetomidine 1mcg IntravenousDEX 1 mcg/kg Intravenously | Drug | DEX 1 mcg/kg Intravenous |
Primary outcome
Maximum blood concentration level of DEX - Cmax
Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
DEX concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
The amount of time that a DEX is present at the maximum concentration - Tmax
Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
DEX concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts (Tmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
Area under the curve for DEX concentration levels
Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
DEX concentration will be measured in the blood samples. Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
Bioavailability of intranasal DEX relative to intravenous DEX for distribution - plasma concentration
Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring distribution for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.
Bioavailability of intranasal DEX relative to intravenous DEX for elimination - plasma concentration
Time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours
Data will also be analyzed using population modeling using nonlinear mixed effect modeling (NONMEM). Investigators are limited in sampling duration to the onset time for cardiopulmonary bypass in this patient population (approximately two hours), investigators will be measuring elimination for approximately one half-life of DEX. This will allow us to estimate the important clinical parameter of relative 0-2h bioavailability of intranasal vs intravenous DEX.
1 secondary outcome
Adverse events associated with DEX administration
Time frame: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Miller, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine 1mcg/kg Intranasal, Dexmedetomidine 2mcg/kg Intranasal and Dexmedetomidine 1mcg Intravenous in people with Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum blood concentration level of DEX - Cmax (time frame: Blood samples will be drawn until immediately prior to Cardiopulmonary bypass, an expected average of 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.