Actively Recruiting
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
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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 mg/kg to 4 mg/kg depending on neuromuscular status, while pyridostigmine doses vary between 200 mcg/kg and 350 mcg/kg 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
Eligibility Criteria
You may qualify if you...
- Patients scheduled elective strabismus surgery aged 4-7
- American Society of Anesthesiologists (ASA) classification 1 or 2
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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo strabismus surgery under general anesthesia and receive either sugammadex or pyridostigmine to reverse neuromuscular blockade at the end of surgery based on specific neuromuscular monitoring.
1 surgery day visit (in-person)
Duration - Until discharge from postanesthesia care unit
Participants are assessed for emergence agitation using the Pediatric Anesthesia Emergence Delirium (PAED) Scale three times at 15-minute intervals in the postanesthesia care unit until discharge.
1 follow-up visit with 3 assessments in PACU
Trial Site Locations
Total: 1 location
1
Konkuk University Medical Center
Seoul, Seoul-T'ǔkpyǒlshi, South Korea, 05030
Actively Recruiting
Research Team
Y
Yea-Ji Lee, M.D Ph. D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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