Deep Neuromuscular Blockade in Strabismus Surgery

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

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 Overview

• Status: Completed
• Conditions: Strabismus
• Intervention / Treatment: Other: moderate to deep neuromuscular blockade; Other: shallow to minimal neuromuscular blockade

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: block group; 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; 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)
Active Comparator: control group; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)	> 20% reduction in heart rate during strabismus surgery	Day 1, During general anesthesia for strabismus surgery (within 2 hours).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Results from a refraction test before strabismus surgery	Results from a refraction test before strabismus surgery measured at outpatient clinic	Before strabismus surgery (within 12 month)
Results from a refraction test at strabismus surgery	Results from a refraction test during strabismus surgery	During general anesthesia for strabismus surgery (within 2 hour)
The incidence of grade 1 oculocardiac reflex (during strabismus surgery)	< 20% reduction in heart rate during general anesthesia for strabismus surgery (within 2 hours).	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	During general anesthesia for strabismus surgery (usually within 2 hour)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Anti-Infective Agents; Physiological Effects of Drugs; Trace Elements; Micronutrients; Anti-Infective Agents, Local; Iodine
• Other Study ID Numbers: H-2303-079-1412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No