The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

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

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Key information

Conditions

Emergence Delirium Confusion Cranial Nerve Diseases Delirium Eye Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric ALL Postoperative Complications Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms Strabismus

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, Seoul-T'ǔkpyǒlshi, 05030, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bridion 200 MG in 2 ML Injection

Drug

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.

Other names: Sugammadex

Pyridostigmine Bromide 5 MG/ML

Drug

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.

Other names: Pyridostigmine

Primary outcomes

The incidence of EA in postanesthesia care unit (PACU)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Sep 13, 2023
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed