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Phase 4
Age: 4Years - 7Years
All Genders
Healthy Volunteers
ID06035757

The Effect of Sugammadex on Emergence Agitation in Pediatric Strabismus Surgery A Prospective Randomized Controlled Trial

Led by Konkuk University Medical Center · Updated on 2026-03-03

76

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether the drug sugammadex can reduce the occurrence of emergence agitation EA, a common complication after general anesthesia, in young children aged 4 to 7 undergoing strabismus surgery. Emergence agitation can be influenced by factors such as postoperative pain, type of surgery, and patient anxiety, which may be related to breathing ability affected by residual neuromuscular blockade after anesthesia. The study uses the Pediatric Anesthesia Emergence Delirium PAED Scale to assess EA in this pediatric population. Participants are randomly assigned to receive one of two reversal agents for neuromuscular blockade at the end of surgery sugammadex or pyridostigmine. The dose of each drug is determined based on neuromuscular monitoring results, such as train-of-four TOF count and posttetanic count PTC. Sugammadex doses range from 2 mgkg to 4 mgkg depending on neuromuscular status, while pyridostigmine doses vary between 200 mcgkg and 350 mcgkg based on TOF count and presence of fade. Children are monitored in the postanesthesia care unit PACU where emergence agitation is assessed three times at 15-minute intervals until discharge. Researchers will observe and record the incidence of EA as the primary outcome. The study is conducted under double-blind conditions with randomized allocation, ensuring unbiased assessment. The total participation covers the surgery period and immediate recovery in PACU, with safety and effectiveness carefully evaluated.

CONDITIONS

Brief Title

The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Who Can Participate

Age: 4Years - 7Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled elective strabismus surgery aged 4-7
  • American Society of Anesthesiologists (ASA) classification 1 or 2
Not Eligible

You will not qualify if you...

  • ASA classification 3 or more
  • Impaired liver function
  • Impaired kidney function
  • Myasthenia gravis or other neuromuscular disorders
  • History of drug allergy
  • Cardiovascular disease or arrhythmia

Research Team

Y

Yea-Ji Lee, M.D Ph. D

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