Deep Neuromuscular Blockade in Strabismus Surgery

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Strabismus

Intervention / Treatment
-----------------
* Other: moderate to deep neuromuscular blockade
* Other: shallow to minimal neuromuscular blockade


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: block group<br>Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg) | Other: moderate to deep neuromuscular blockade<br>* 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)<br>|
| Active Comparator: control group<br>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) | Other: shallow to minimal neuromuscular blockade<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grade 2 or greater oculocardiac reflex (induced) | > 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle | During induced oculocardiac reflex test by ophthalmologists | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grade 1 oculocardiac reflex (induced) | < 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle | During induced oculocardiac reflex test by ophthalmologists | 
| The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery) | > 20% reduction in heart rate during strabismus surgery | During general anesthesia for strabismus surgery (within 2 hour) | 
| The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery) | < 20% reduction in heart rate during strabismus surgery | During general anesthesia for strabismus surgery (usually within 2 hour) | 
| Number of times Rescue IV Atropine has been used for oculocardiac reflex | Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex | During general anesthesia for strabismus surgery (within 2 hour) | 
| The incidence of hypotension | The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure | During general anesthesia for strabismus surgery (within 2 hour) | 
| Postoperative nausea/vomiting | Presence of postoperative nausea/vomiting as assessed in the recovery room | From extubation to post-anesthesia care unit stay (within 1 hour) |