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Completed

NCT Number: NCT05882643

Deep Neuromuscular Blockade in Strabismus Surgery

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.

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Key information

Conditions

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

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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)

Primary outcomes

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

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

    > 20% reduction in heart rate during strabismus surgery

Secondary outcomes

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

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

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

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

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

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

  3. The incidence of hypotension

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

    The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure

  4. Postoperative nausea/vomiting

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

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

  5. Results from a refraction test before strabismus surgery

    Time frame: Before strabismus surgery (within 12 month)

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

  6. Results from a refraction test at strabismus surgery

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

    Results from a refraction test during strabismus surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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