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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Drug Allergy
• Drug Hypersensitivity
• Neuromuscular Blockade

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)