RecruitingPhase 4NCT06035757

The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial


Sponsor

Konkuk University Medical Center

Enrollment

76 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The present trial conducted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incidence of emergence agitation (EA) comparing to neostigmine


Eligibility

Min Age: 4 YearsMax Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how often children experience "emergence agitation" — a state of confusion, distress, or restlessness when waking up from general anesthesia — during strabismus (crossed-eyes) surgery, and what factors might cause it. **You may be eligible if...** - Your child is between 4 and 7 years old - Your child is scheduled for elective strabismus surgery - Your child is classified as ASA 1 or 2 (generally healthy or mild systemic disease) **You may NOT be eligible if...** - Your child is classified as ASA 3 or higher (significant systemic disease) - Your child has impaired liver or kidney function - Your child has a neuromuscular disorder (e.g., myasthenia gravis) - Your child has a history of drug allergy - Your child has a heart condition or arrhythmia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBridion 200 MG in 2 ML Injection

Sugammadex is administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each reversal agent is determined with response to TOF or PTC.

DRUGPyridostigmine Bromide 5 MG/ML

Pyridostigmine is administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each reversal agent is determined with response to TOF.


Locations(1)

Konkuk University Medical Center

Seoul, Seoul-T'ǔkpyǒlshi, South Korea

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NCT06035757


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