Drug AllergyNCT05820802
High Dimensional Analysis of Immune Cells in Pediatric Patients
An observational study of Drug Allergy and Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing neuromuscular blocking agent, in the event of an allergic reaction. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Allergy, Neuromuscular Blockade
- How many people
- 294 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2023to 1 Dec 2026
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients between the ages of 2 and 18 undergoing general anesthesia using the rocuronium.
Who may be able to join
- Pediatric patients between the ages of 2 and 18 undergoing general anesthesia and surgery using the neuromuscular blocker, rocuronium.
Who cannot join
- Patients who have received immunomodulators, immunosuppressants, etc.
- Patients with autoimmune diseases (rheumatoid arthritis, lupus, Behcet's disease, etc.)
- Patients who regularly take, or have taken within 4 weeks, medications that may affect the immune system (oral steroids, anti-inflammatories, etc.)
- Other cases where the Principal Investigator determines that it is difficult to conduct the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Young-Eun Jang, MD, PhD, 82-2-2072-3650, na0ag2@hotmail.com
About this study
Official title: High Dimensional Analysis of Immune Cells Using scRNA-seq in Pediatric Patients With Allergic Reactions to Neuromuscular Blockers
The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing neuromuscular blocking agent, in the event of an allergic reaction.
- Conditions
- Drug Allergy, Neuromuscular Blockade
- Medical subject headings
- Drug Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic profile analysis of the T lymphocytes by RNA sequencing
Blood sample from the patients when patient shows allergic reaction after administration of rocuronium
Measured: until end of surgery (usually up to 12 hours from the first dose of rocuronium)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start27 Apr 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AllergyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Eun Jang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820802
- Sponsor's protocol ID
- 2208-169-1354
- Status last verified
- Nov 2024
- First submitted
- 22 Mar 2023
- Last updated
- 29 Nov 2024
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dimensional Analysis of Immune Cells Using scRNA-seq in Pediatric Patients With Allergic Reactions to Neuromuscular Blockers
- ClinicalTrials.gov ID
- NCT05820802
- Acronym / sponsor ID
- 2208-169-1354
- Conditions
- Drug Allergy, Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Apr 2023 (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.
The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing neuromuscular blocking agent, in the event of an allergic reaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients between the ages of 2 and 18 undergoing general anesthesia using the rocuronium.
Key inclusion criteria (1 listed)
- Pediatric patients between the ages of 2 and 18 undergoing general anesthesia and surgery using the neuromuscular blocker, rocuronium.
Key exclusion criteria (4 listed)
- Patients who have received immunomodulators, immunosuppressants, etc.
- Patients with autoimmune diseases (rheumatoid arthritis, lupus, Behcet's disease, etc.)
- Patients who regularly take, or have taken within 4 weeks, medications that may affect the immune system (oral steroids, anti-inflammatories, etc.)
- Other cases where the Principal Investigator determines that it is difficult to conduct the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transcriptomic profile analysis of the T lymphocytes by RNA sequencing
Time frame: until end of surgery (usually up to 12 hours from the first dose of rocuronium)
Blood sample from the patients when patient shows allergic reaction after administration of rocuronium
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 29 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Allergy and Neuromuscular Blockade, 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: looking for participants now, as of the sponsor's last update on 29 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic profile analysis of the T lymphocytes by RNA sequencing (time frame: until end of surgery (usually up to 12 hours from the first dose of rocuronium)). 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 29 Nov 2024.