The Effect of the Deep Neuromuscular Block on the Refraction and the Oculocardiac Reflex During Strabismus Surgery in Pediatric Patients - a Prospective Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country204 target enrollmentAugust 28, 2024

ConditionsStrabismus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Strabismus
Sponsor: Seoul National University Hospital
Enrollment: 204
Locations: 1
Primary Endpoint: The incidence of grade 2 or greater oculocardiac reflex (induced, during strabismus surgery)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 28, 2024

End Date

June 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Young-Eun Jang

Clinical Associate Professor

Seoul National University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The incidence of grade 2 or greater oculocardiac reflex (induced, during strabismus surgery)

Time Frame: During induced oculocardiac reflex test by ophthalmologists

\> 20% reduction in heart rate induced by intentional manipulation of the extraocular rectus muscle

Secondary Outcomes

The incidence of grade 1 oculocardiac reflex (induced, during strabismus surgery)(During induced oculocardiac reflex test by ophthalmologists)
Number of times Rescue IV Atropine has been used for oculocardiac reflex(During general anesthesia for strabismus surgery (within 2 hour))
Results from a refraction test before strabismus surgery(Before strabismus surgery (within 12 month))
The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)(During general anesthesia for strabismus surgery (within 2 hour))
Postoperative nausea/vomiting(From extubation to post-anesthesia care unit stay (within 1 hour))
The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery)(During general anesthesia for strabismus surgery (usually within 2 hour))
Results from a refraction test at strabismus surgery(During general anesthesia for strabismus surgery (within 2 hour))
The incidence of hypotension(During general anesthesia for strabismus surgery (within 2 hour))