High Dimensional Analysis of Immune Cells in Pediatric Patients

Recruiting

• Conditions: Neuromuscular Blockade; Drug Allergy

• Registration Number: NCT05820802
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-20
• Study Start: 2023-04-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-04-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 294

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcriptomic profile analysis of the T lymphocytes by RNA sequencing	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of