DexmedetomidineNCT03234660
Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia
A study testing Dexmedetomidine Hydrochloride in people with Dexmedetomidine, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- Dexmedetomidine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 5 Oct 2019
- Phase
- Interventional
- 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 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children undergoing general anesthesia longer than 3 hours
Who cannot join
- past history of anesthesia
- cardiopulmonary bypass
- preexisting neurocognitive dysfunction
- abnormalities of liver profile (aspartate transaminase > 40 unit/L, alanine aminotransferase > 40 unit/L)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein
Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.
Read the detailed description
GFAP measure
- Conditions
- Dexmedetomidine
- Being tested
- Dexmedetomidine Hydrochloride, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery
controlOther
0.9% normal saline continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | dexmedetomidine infusion Receives: Drug: Dexmedetomidine Hydrochloride |
| control | Placebo comparator | placebo infusion Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glial fibrillary acid protein
plasma was collected at the given specific time
Measured: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Sep 2017
- Primary completion5 Oct 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234660
- Sponsor's protocol ID
- H1706-132-861
- Status last verified
- Dec 2019
- First submitted
- 17 Jul 2017
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein
- ClinicalTrials.gov ID
- NCT03234660
- Acronym / sponsor ID
- H1706-132-861
- Conditions
- Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 31 Jul 2017 (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.
Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.
Detailed description
GFAP measure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine Hydrochloridedexmedetomidine infusion |
| control | Placebo comparator | Other: controlplacebo infusion |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children undergoing general anesthesia longer than 3 hours
Key exclusion criteria (4 listed)
- past history of anesthesia
- cardiopulmonary bypass
- preexisting neurocognitive dysfunction
- abnormalities of liver profile (aspartate transaminase > 40 unit/L, alanine aminotransferase > 40 unit/L)
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 Hydrochloridedexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery | Drug | Dexmedetomidine |
| control0.9% normal saline continuous infusion | Other | control |
Primary outcome
Glial fibrillary acid protein
Time frame: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction
plasma was collected at the given specific time
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 2 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Hydrochloride in people with Dexmedetomidine, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 2 Jan 2020. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Glial fibrillary acid protein (time frame: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction). 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 2 Jan 2020.