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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06035757

Enrollment

Registered

2023-09-13

Start date

2023-12-01

Completion date

2026-03-13

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Pediatric ALL, Strabismus

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

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.

Interventions

DRUGBridion 200 MG in 2 ML Injection

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.

DRUGPyridostigmine Bromide 5 MG/ML

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 7 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients scheduled elective strabismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of EA in postanesthesia care unit (PACU)	EA is assessed three times at 15-minute intervals in PACU until discharge from PACU.	EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORYea-Ji Lee, M.D Ph. D

Konkuk University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026