The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-7
SponsorKonkuk University Medical Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Patients scheduled elective strabismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3.
Disqualifiers
ASA classification 3 or more
impaired liver function
impaired kidney function
myasthenia gravis or other neuromuscular disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Bridion 200 MG in 2 ML Injection
DrugSugammadex 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 Bromide 5 MG/ML
DrugPyridostigmine 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: group pyridostigmineActive comparator 1 intervention
Group B: group sugammadexActive comparator 1 intervention
Trial outcomes
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.
Time frame
EA is assessed three times at 15-minute intervals in PACU until discharge from PACU.Sponsors and contacts
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Source ClinicalTrials.gov