Deep Neuromuscular Blockade in Strabismus Surgery

Seoul National University Hospital204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

204

Conditions

Strabismus

Interventions

moderate to deep neuromuscular blockadeOTHER

* 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)

shallow to minimal neuromuscular blockadeOTHER

* 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)

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: During induced oculocardiac reflex test by ophthalmologists

Secondary Outcomes

The incidence of grade 1 oculocardiac reflex (induced, during strabismus surgery)

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: During general anesthesia for strabismus surgery (within 2 hour)

Postoperative nausea/vomiting

Data from ClinicalTrials.gov

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