Strabismus
Conditions
Brief summary
The purpose of this study is to determine if inducing a moderate or greater neuromuscular block (TOF count 0-3) when performing a neuromuscular block in pediatric patients aged 3 to 18 years undergoing strabismus surgery under general anesthesia can reduce the incidence of the oculocardiac reflex.
Interventions
OTHERmoderate to deep neuromuscular blockade
* Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3 count, post-tetanic count \> 1) * Rocuronium (intravenous, 1.0 mg/kg at induction period)
OTHERshallow to minimal neuromuscular blockade
* Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count \< 0.9) * Rocuronium (intravenous, 0.3 mg/kg at induction period)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Pediatric patients between the ages of 3 and 18 who are American Society of Anesthesiologists physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia.
Exclusion criteria
* Patients with underlying cardiovascular disease * Patients with preoperative electrocardiograms showing conduction disturbances * Patients with neuromuscular disease * Any other patient who, in the opinion of the investigator, is not a good candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery) | Day 1, During general anesthesia for strabismus surgery (within 2 hours). | \> 20% reduction in heart rate during strabismus surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 1 oculocardiac reflex (during strabismus surgery) | Day 1, During general anesthesia for strabismus surgery (within 2 hours). | \< 20% reduction in heart rate during general anesthesia for strabismus surgery (within 2 hours). |
| The incidence of grade 3 or greater oculocardiac reflex (during strabismus surgery) | During general anesthesia for strabismus surgery (usually within 2 hour) | \> 30% decrease in heart rate (moderate oculocardiac reflex) during strabismus surgery |
| The incidence of hypotension | During general anesthesia for strabismus surgery (within 2 hour) | The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure |
| Postoperative nausea/vomiting | From extubation to post-anesthesia care unit stay (within 1 hour) | Presence of postoperative nausea/vomiting as assessed in the recovery room |
| Results from a refraction test before strabismus surgery | Before strabismus surgery (within 12 month) | Results from a refraction test before strabismus surgery measured at outpatient clinic |
| Results from a refraction test at strabismus surgery | During general anesthesia for strabismus surgery (within 2 hour) | Results from a refraction test during strabismus surgery |
Countries
South Korea
Outcome results
None listed