RetinoblastomaNCT04700514
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
A study testing Dexmedetomidine in people with Retinoblastoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2021to 20 Feb 2025
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Ji-Hyun LEE, MD, PhD, 02-2072-3661 ext. 82, muslab@hanmail.net
About this study
This study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4.
- Conditions
- Retinoblastoma
- Being tested
- Dexmedetomidine
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine (1 mcg/kg loading for 10 min, then 1 mcg/kg/min continuous infusion) is used with sevoflurane in every time of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 1. Children diagnosed with retinoblastoma and received exam under anesthesia (EUA) before the age of 30 months, and is not yet 4 years old 2. Children who are undergoing exams and treatment such as EUA, chemoport insertion, or intra-arterial chemotherapy under general anesthesia 3. Sevoflurane is used only for anesthesia |
| Dexmedetomidine group | Experimental | 1. Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months.
2. No history of anesthesia Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
IQ score at age of 4
Korean-Wechsler Preschool and Primary Scale of Intelligence test (score >131, high; score 116-130, high-normal; socre 85-115, normal; score 70-84; low-normal; score <69; low)
Measured: year 4
Developmental Test
visual-Motor Integration test
Measured: year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start5 Feb 2021
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700514
- Sponsor's protocol ID
- 2009-039-1155
- Status last verified
- Apr 2023
- First submitted
- 4 Jan 2021
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
- ClinicalTrials.gov ID
- NCT04700514
- Acronym / sponsor ID
- 2009-039-1155
- Conditions
- Retinoblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 8 Jan 2021 (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 study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –1. Children diagnosed with retinoblastoma and received exam under anesthesia (EUA) before the age of 30 months, and is not yet 4 years old 2. Children who are undergoing exams and treatment such as EUA, chemoport insertion, or intra-arterial chemotherapy under general anesthesia 3. Sevoflurane is used only for anesthesia |
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine1. Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months. 2. No history of anesthesia |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine (1 mcg/kg loading for 10 min, then 1 mcg/kg/min continuous infusion) is used with sevoflurane in every time of general anesthesia | Drug | Dexmedetomidine group |
Primary outcome
IQ score at age of 4
Time frame: year 4
Korean-Wechsler Preschool and Primary Scale of Intelligence test (score >131, high; score 116-130, high-normal; socre 85-115, normal; score 70-84; low-normal; score <69; low)
Developmental Test
Time frame: year 4
visual-Motor Integration test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
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 in people with Retinoblastoma, 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 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hyun Lee, MD, PhD (01076658848 ext. 82, muslab@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IQ score at age of 4 (time frame: year 4). 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 24 Apr 2023.