StrabismusNCT05882643
Deep Neuromuscular Blockade in Strabismus Surgery
A study testing moderate to deep neuromuscular blockade and shallow to minimal neuromuscular blockade in people with Strabismus, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Strabismus
- What is being tested?
- moderate to deep neuromuscular blockade and shallow to minimal neuromuscular blockade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- moderate to deep neuromuscular blockade, shallow to minimal neuromuscular blockade
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: shallow to minimal neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)
> 20% reduction in heart rate during strabismus surgery
Measured: Day 1, During general anesthesia for strabismus surgery (within 2 hours).
Secondary outcomes (6)
The incidence of grade 1 oculocardiac reflex (during strabismus surgery)
< 20% reduction in heart rate during general anesthesia for strabismus surgery (within 2 hours).
Measured: 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
Measured: 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
Measured: During general anesthesia for strabismus surgery (within 2 hour)
Postoperative nausea/vomiting
Presence of postoperative nausea/vomiting as assessed in the recovery room
Measured: 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
Measured: Before strabismus surgery (within 12 month)
Results from a refraction test at strabismus surgery
Results from a refraction test during strabismus surgery
Measured: During general anesthesia for strabismus surgery (within 2 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start2 Oct 2024
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Eun Jang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882643
- Sponsor's protocol ID
- H-2303-079-1412
- Status last verified
- Apr 2026
- First submitted
- 22 May 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JB, Jung JH, Ji SH, Kim EH, Lee JH, Kim JT, Kim HS, Jang YE. Neuromuscular Blockade Depth and Oculocardiac Reflex in Pediatric Strabismus Surgery: A Randomized Clinical Trial. Anesthesiology. 2026 Nov 1;145(5):1107-1116. doi: 10.1097/ALN.0000000000006256. Epub 2026 Jul 16.
PubMed 42461097
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05882643
- Acronym / sponsor ID
- H-2303-079-1412
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| block group | Experimental | Other: moderate to deep neuromuscular blockade* 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) |
| control group | Active comparator | 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) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | block group |
| 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) | Other | control group |
Primary outcome
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
6 secondary outcomes
The incidence of grade 1 oculocardiac reflex (during strabismus surgery)
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)
Time frame: During general anesthesia for strabismus surgery (usually within 2 hour)
The incidence of hypotension
Time frame: During general anesthesia for strabismus surgery (within 2 hour)
Postoperative nausea/vomiting
Time frame: From extubation to post-anesthesia care unit stay (within 1 hour)
Results from a refraction test before strabismus surgery
Time frame: Before strabismus surgery (within 12 month)
Results from a refraction test at strabismus surgery
Time frame: During general anesthesia for strabismus surgery (within 2 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Derived from this study: PubMed 42461097Park JB, Jung JH, Ji SH, Kim EH, Lee JH, Kim JT, Kim HS, Jang YE. Neuromuscular Blockade Depth and Oculocardiac Reflex in Pediatric Strabismus Surgery: A Randomized Clinical Trial. Anesthesiology. 2026 Nov 1;145(5):1107-1116. doi: 10.1097/ALN.0000000000006256. Epub 2026 Jul 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate to deep neuromuscular blockade and shallow to minimal neuromuscular blockade in people with Strabismus, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.