The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Konkuk University Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Strabismus; Emergence Delirium; Pediatric ALL

Treatments: Drug: Bridion 200 MG in 2 ML Injection; Drug: Pyridostigmine Bromide 5 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT06035757

KUMC2023-05-082

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

group pyridostigmine

Active Comparator group

Description:

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.

Treatment:

Drug: Pyridostigmine Bromide 5 MG/ML

group sugammadex

Active Comparator group

Description:

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.

Treatment:

Drug: Bridion 200 MG in 2 ML Injection