The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Phase 4

Recruiting

• Conditions: Emergence Delirium; Strabismus; Pediatric ALL
• Interventions: Drug: Pyridostigmine Bromide 5 MG/ML; Drug: Bridion 200 MG in 2 ML Injection

• Registration Number: NCT06035757
• Lead Sponsor: Konkuk University Medical Center

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.

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Study Start: 2023-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group pyridostigmine	Pyridostigmine Bromide 5 MG/ML	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.
group sugammadex	Bridion 200 MG in 2 ML Injection	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Seoul-T'ǔkpyǒlshi, Korea, Republic of