NCT05820802

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

March 22, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 27, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

March 22, 2023

Last Update Submit

November 26, 2024

Conditions

Drug AllergyNeuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients between the ages of 2 and 18 undergoing general anesthesia using the rocuronium.

You may qualify if:

  • Pediatric patients between the ages of 2 and 18 undergoing general anesthesia and surgery using the neuromuscular blocker, rocuronium.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 20, 2023

Study Start

April 27, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

KR(1)