Heart DiseasesPhase 1DexPKNCT03668951
Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
A Phase 1 study testing Dexmedetomidine buccal and Dexmedetomidine Intranasal in people with Heart Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 48 months
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Dexmedetomidine buccal and Dexmedetomidine Intranasal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 3 May 2022
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- Dexmedetomidine buccal, Dexmedetomidine Intranasal
- 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 buccalDrug
DEX 2 mcg/kg buccal
Dexmedetomidine IntranasalDrug
DEX 3 mcg/kg intranasal
Dexmedetomidine IntranasalDrug
DEX 4 mcg/kg intranasal
| Study group | Role | What they receive |
|---|---|---|
| Buccal DEX 2 mcg/kg | 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 buccal |
| Intranasal DEX 3 mcg/kg | 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 Intranasal |
| Intranasal DEX 4 mcg/kg | 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 Intranasal |
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).
Measured: 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
Dex concentration will be measured in the blood to determine the time point with the maximum concentration and how long that maximum concentration lasts.
Measured: Blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .
Secondary outcomes (5)
Area under the curve for Dex concentration levels
Dex concentration will be measured in the blood samples.
Measured: 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
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.
Measured: 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.
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.
Measured: 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
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.
Measured: Participants will be followed until cardiopulmonary bypass, an expected duration of 2 hours.
Systolic and diastolic blood pressure with Dex administration
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.
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 posted13 Sep 2018
- Study start20 Aug 2018
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Jayant Pratap, MA,MB BChir,MRCPCH,FRCA, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668951
- Sponsor's protocol ID
- 2018-3034
- Acronym
- DexPK
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
- ClinicalTrials.gov ID
- NCT03668951
- Acronym / sponsor ID
- DexPK / 2018-3034
- Conditions
- Heart Diseases
- 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
- 20 Aug 2018 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buccal DEX 2 mcg/kg | Experimental | Drug: Dexmedetomidine buccalStandard 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. |
| Intranasal DEX 3 mcg/kg | Experimental | Drug: Dexmedetomidine 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. |
| Intranasal DEX 4 mcg/kg | Experimental | Drug: Dexmedetomidine 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. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 buccalDEX 2 mcg/kg buccal | Drug | Buccal DEX 2 mcg/kg |
| Dexmedetomidine IntranasalDEX 3 mcg/kg intranasal | Drug | Intranasal DEX 3 mcg/kg |
| Dexmedetomidine IntranasalDEX 4 mcg/kg intranasal | Drug | Intranasal DEX 4 mcg/kg |
Primary outcome
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).
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.
5 secondary outcomes
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 .
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 .
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 .
Adverse events associated with Dex administration
Time frame: 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.
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 8 Feb 2023.
- 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.
Jayant Pratap, MA,MB BChir,MRCPCH,FRCA 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 buccal and Dexmedetomidine Intranasal in people with Heart Diseases, 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 4 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 8 Feb 2023. 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 at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after Dex has been .). The study lists 2 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 8 Feb 2023.