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
1 other identifier
interventional
76
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2023
Typical duration for phase_4
1 active site
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
First Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedMarch 3, 2026
March 1, 2026
2.3 years
September 6, 2023
March 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of EA in postanesthesia care unit (PACU)
EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.
EA is assessed three times at 15-minute intervals in PACU until discharge from PACU.
Study Arms (2)
group pyridostigmine
ACTIVE COMPARATORIf TOF count is 1 or less, wait until it becomes 2 and then give the patient pyridostigmine dose of 350mcg/kg. If TOF count shows 4 with fade, 350mcg/kg of pyridostigmine is administered and without fade, 200mcg/kg is administered.
group sugammadex
ACTIVE COMPARATORIf TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugammadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients scheduled elective strabismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Medical Center
Seoul, Seoul-T'ǔkpyǒlshi, 05030, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yea-Ji Lee, M.D Ph. D
Konkuk University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant professor
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 13, 2023
Study Start
December 1, 2023
Primary Completion
March 30, 2026
Study Completion
March 30, 2026
Last Updated
March 3, 2026
Record last verified: 2026-03