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CompletedNCT05882643Updated Apr 23, 2026

Deep Neuromuscular Blockade in Strabismus Surgery

An interventional study of moderate to deep neuromuscular blockade and shallow to minimal neuromuscular blockade in Strabismus, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Strabismus

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03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's enrollment of 201 is above the median of 60 across 82 interventional studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pediatric patients between the ages of 3 and 18 who are physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia.

Exclusion criteria

Exclusion Criteria:

  • Patients with underlying cardiovascular disease
  • Patients with preoperative 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
201 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Othermoderate 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)

  • Othershallow 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)

06

What researchers measure

Primary outcomes

  1. 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

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Results from a refraction test at strabismus surgery

    Results from a refraction test during strabismus surgery

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

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Nov 2025, 13 months.

Of 35 non-industry interventional studies with no phase under Strabismus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's 13 months is below that.

Counting every sponsor, half of 35 studies reached it within 17 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2023
First posted
May 31, 2023
StartActual
Oct 2, 2024
Primary completionActual
Nov 26, 2025
CompletionActual
Nov 26, 2025
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05882643
Responsible party
Young-Eun Jang (Clinical Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
May 31, 2023
Start date
Oct 2, 2024
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025
Last update
Apr 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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