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NCT05820802 Clinical Trial

High Dimensional Analysis of Immune Cells in Pediatric Patients

Neuromuscular Blockade Clinical Trial

Official title:
High Dimensional Analysis of Immune Cells Using scRNA-seq in Pediatric Patients With Allergic Reactions to Neuromuscular Blockers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05820802
Other study ID # 2208-169-1354
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 27, 2023
Est. completion date December 1, 2026

Study information
Verified date May 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 294
Est. completion date December 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - Pediatric patients between the ages of 2 and 18 undergoing general anesthesia and surgery using the neuromuscular blocker, rocuronium. Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Transcriptomic profile analysis of the T lymphocytes by RNA sequencing Blood sample from the patients when patient shows allergic reaction after administration of rocuronium until end of surgery (usually up to 12 hours from the first dose of rocuronium)
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