Anesthesia and NeurotoxicityNCT04364945
Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children
A study testing dexmedetomidine, remifentanil and Sevoflurane in people with Anesthesia and Neurotoxicity, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 month to 23 months
- Conditions the study is for
- Anesthesia and Neurotoxicity
- What is being tested?
- dexmedetomidine, remifentanil and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2020to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under 2 years of age who underwent general anesthesia for elective surgeries inlcuding urology, surgery, plastic surgery, orthopedics, and otolaryngology, etc, which were non-staged and non-repetitive procedures
- American Society of Anesthesiology Physical Status I, II
Who cannot join
- Allergies to narcotic analgesics
- With massive bleeding or shock
- Heart, lung, kidney or liver disease
- Central / peripheral nervous system disease and disorder
- Any physical deformity and disorder, genetic disease, chromosomal disease
- Previous history of general anesthesia or sedation
- Developmental delay identified through K-DST results
- Additional exposure to general anesthetics or sedative drugs during follow-up
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.
- Conditions
- Anesthesia and Neurotoxicity
- Being tested
- dexmedetomidine, remifentanil, Sevoflurane
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
administration of dexmedetomidine 1 mcg/kg/hr
remifentanilDrug
administration of remifentanil 0.1-0.2 mcg/kg/min
SevofluraneDrug
Anesthesia is maintained using sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. Receives: Drug: Sevoflurane |
| Dexmedetomidine-remifentanil(DEX-R) group | Experimental | General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. Receives: Drug: dexmedetomidine; Drug: remifentanil; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline
Measured: When the patient's age is 5 years after surgery
Secondary outcomes (3)
Leiter International Performance Scale at age of 30 months
Korean version of the Leiter International Performance Scale-Revised (Leiter-R), categorization:
130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline
Measured: When the patient's age is 30 months old after surgery
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7
categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline
Measured: When the patient's age is 7 years old after surgery
Child Behavior Checklist results
Child Behavior Checklist results at age of 30 months, 5 years and 7 years
Measured: When the patient's age become 30 months, 5 years and 7 years old after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start17 Jun 2020
- Primary completion30 May 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia and NeurotoxicityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 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
- Investigators
- Ji-Hyun Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364945
- Sponsor's protocol ID
- H2003-234-1115
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2020
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ji SH, Kang P, Cho SA, Park JB, Jang YE, Kim EH, Kim JT, Kim HS, Jung HJ, Jung HA, Lee HC, Lee JH. Effects of Dexmedetomidine-Remifentanil on Neurodevelopment of Children after Inhalation Anesthesia: A Randomized Clinical Trial. Anesthesiology. 2025 Oct 1;143(4):827-834. doi: 10.1097/ALN.0000000000005634. Epub 2025 Sep 9.
PubMed 40923823
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children
- ClinicalTrials.gov ID
- NCT04364945
- Acronym / sponsor ID
- H2003-234-1115
- Conditions
- Anesthesia and Neurotoxicity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 28 Apr 2020 (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.
In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: SevofluraneGeneral anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. |
| Dexmedetomidine-remifentanil(DEX-R) group | Experimental | Drug: dexmedetomidine, Drug: remifentanil, Drug: SevofluraneGeneral anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60. |
Who may qualify
- Ages
- 1 month to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children under 2 years of age who underwent general anesthesia for elective surgeries inlcuding urology, surgery, plastic surgery, orthopedics, and otolaryngology, etc, which were non-staged and non-repetitive procedures
- American Society of Anesthesiology Physical Status I, II
Key exclusion criteria (8 listed)
- Allergies to narcotic analgesics
- With massive bleeding or shock
- Heart, lung, kidney or liver disease
- Central / peripheral nervous system disease and disorder
- Any physical deformity and disorder, genetic disease, chromosomal disease
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 |
|---|---|---|
| dexmedetomidineadministration of dexmedetomidine 1 mcg/kg/hr | Drug | Dexmedetomidine-remifentanil(DEX-R) group |
| remifentaniladministration of remifentanil 0.1-0.2 mcg/kg/min | Drug | Dexmedetomidine-remifentanil(DEX-R) group |
| SevofluraneAnesthesia is maintained using sevoflurane. | Drug | Control group, Dexmedetomidine-remifentanil(DEX-R) group |
Primary outcome
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
Time frame: When the patient's age is 5 years after surgery
categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline
3 secondary outcomes
Leiter International Performance Scale at age of 30 months
Time frame: When the patient's age is 30 months old after surgery
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7
Time frame: When the patient's age is 7 years old after surgery
Child Behavior Checklist results
Time frame: When the patient's age become 30 months, 5 years and 7 years old after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 40923823Ji SH, Kang P, Cho SA, Park JB, Jang YE, Kim EH, Kim JT, Kim HS, Jung HJ, Jung HA, Lee HC, Lee JH. Effects of Dexmedetomidine-Remifentanil on Neurodevelopment of Children after Inhalation Anesthesia: A Randomized Clinical Trial. Anesthesiology. 2025 Oct 1;143(4):827-834. doi: 10.1097/ALN.0000000000005634. Epub 2025 Sep 9.
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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.
Ji-Hyun Lee, MD, PhD principal investigator
Seoul National University Hospital
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, remifentanil and Sevoflurane in people with Anesthesia and Neurotoxicity, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5 (time frame: When the patient's age is 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364945, which also lists 1 linked publication.
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 19 Nov 2024.