NCT06035757

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: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Emergence Delirium
• Strabismus
• Pediatric ALL

Interventions

Type	Name	Description
DRUG	Bridion 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.
DRUG	Pyridostigmine 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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2023-09-13
• Last updated: 2026-03-03

Locations

1 site across 1 country: South Korea