Deep Neuromuscular Blockade in Strabismus Surgery

NCT05882643 | Completed

• 1 other identifier: H-2303-079-1412
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

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

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

  During general anesthesia for strabismus surgery (usually within 2 hour)

• The incidence of hypotension

  During general anesthesia for strabismus surgery (within 2 hour)

• Postoperative nausea/vomiting

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

• Results from a refraction test before strabismus surgery

  Before strabismus surgery (within 12 month)

Study Arms (2)

block group

EXPERIMENTAL

* 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

control group

ACTIVE COMPARATOR

* 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

Interventions

moderate to deep neuromuscular blockade OTHER

* 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)

block group

shallow to minimal neuromuscular blockade OTHER

* 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)

control group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 31, 2023
• Study Start: October 2, 2024
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

KR (1)