Deep Neuromuscular Blockade in Strabismus Surgery

Seoul National University Hospital201 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

201

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

Outcomes

Primary Outcomes

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

\> 20% reduction in heart rate during strabismus surgery

Time frame: Day 1, During general anesthesia for strabismus surgery (within 2 hours).

Secondary Outcomes

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

\< 20% reduction in heart rate during general anesthesia for strabismus surgery (within 2 hours).

Time frame: Day 1, During general anesthesia for strabismus surgery (within 2 hours).

The incidence of grade 3 or greater oculocardiac reflex (during strabismus surgery)

\> 30% decrease in heart rate (moderate oculocardiac reflex) during strabismus surgery

Time frame: During general anesthesia for strabismus surgery (usually 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

Presence of postoperative nausea/vomiting as assessed in the recovery room

Time frame: From extubation to post-anesthesia care unit stay (within 1 hour)

Results from a refraction test before strabismus surgery

Results from a refraction test before strabismus surgery measured at outpatient clinic

Time frame: Before strabismus surgery (within 12 month)

Results from a refraction test at strabismus surgery

Data from ClinicalTrials.gov

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