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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05882643
Other study ID # H-2303-079-1412
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date June 1, 2026

Study information

Verified date April 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 204
Est. completion date June 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of grade 2 or greater oculocardiac reflex (induced) > 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle During induced oculocardiac reflex test by ophthalmologists
Secondary The incidence of grade 1 oculocardiac reflex (induced) < 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle During induced oculocardiac reflex test by ophthalmologists
Secondary The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery) > 20% reduction in heart rate during strabismus surgery During general anesthesia for strabismus surgery (within 2 hour)
Secondary The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery) < 20% reduction in heart rate during strabismus surgery During general anesthesia for strabismus surgery (usually within 2 hour)
Secondary Number of times Rescue IV Atropine has been used for oculocardiac reflex Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex During general anesthesia for strabismus surgery (within 2 hour)
Secondary 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)
Secondary 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)
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