The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- The incidence of EA in postanesthesia care unit (PACU)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
group sugammadex
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.
Intervention: Bridion 200 MG in 2 ML Injection (Drug)
group pyridostigmine
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.
Intervention: Pyridostigmine Bromide 5 MG/ML (Drug)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yea-Ji Lee
Assisstant professor
Konkuk University Medical Center