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CompletedNCT06035757Updated Jul 15, 2026

The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

A Phase 4 interventional study of Bridion 200 MG in 2 ML Injection and Pyridostigmine Bromide 5 MG/ML in Emergence Delirium, Strabismus and Pediatric ALL, sponsored by Konkuk University Medical Center. Completed at 1 site in South Korea. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
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Study 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

Read the detailed description

EA is one of the most common postoperative complications in after general anesthesia in pre-school aged pediatric patients. There are several causes contributed to occurrence of EA such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia. Some researches showed that the occurrence of EA is associated with patients' anxiety and investigators of this trial inferred that patients' anxiety after general anesthesia could be related to ability to breathe. Ability to breathe is highly associated with level of residual neuromuscular blockade (NMB) after recovery from general anesthesia. Investigators evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB reduces the incidence of EA in pediatric patients who undergo strabismus surgery.

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Conditions studied

03

In context

Emergence Delirium

751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's enrollment of 76 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients scheduled elective strabismus surgery aged 4-7 with (ASA) classification 1-3.

Exclusion criteria

Exclusion Criteria:

  • 3 or more
  • impaired liver function
  • impaired kidney function
  • myasthenia gravis or other neuromuscular disorders
  • history of drug allergy
  • cardiovascular disease or arrhythmia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    group pyridostigmine

    If 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.

    Drug: Pyridostigmine Bromide 5 MG/ML

  • Active comparator
    group sugammadex

    If 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.

    Drug: Bridion 200 MG in 2 ML Injection

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.

    Also known as: Sugammadex

  • DrugPyridostigmine Bromide 5 MG/ML

    Drug page: Pyridostigmine

    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.

    Also known as: Pyridostigmine

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What researchers measure

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.

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Study locations

1 site
  • Konkuk University Medical Center
    Seoul, Seoul-T'ǔkpyǒlshi 05030, South Korea
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06035757
Lead sponsor
Konkuk University Medical Center
Responsible party
Yea-Ji Lee (Assisstant professor, Konkuk University Medical Center) — Principal investigator
First posted
Sep 13, 2023
Start date
Dec 1, 2023
Primary completion
Mar 13, 2026
Completion
Mar 13, 2026
Last update
Jul 15, 2026

Study contacts

Yea-Ji Lee, M.D Ph. D
principal investigator · Konkuk University Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Sugammadex · Pyridostigmine

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