Using deep neuromuscular blockade during strabismus surgery in children
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
NA · Seoul National University Hospital · NCT05882643
This study is testing if using a deeper level of muscle relaxation during eye surgery in children can help prevent a specific complication that can happen during the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05882643 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of moderate to deep neuromuscular blockade on pediatric patients aged 3 to 18 years undergoing strabismus surgery under general anesthesia. The primary focus is to determine if a deeper neuromuscular block can reduce the incidence of the oculocardiac reflex, a potential complication during the procedure. Participants will be monitored for their neuromuscular function and the outcomes will be compared between different levels of neuromuscular blockade. The study will include patients classified as ASA I, II, or III, ensuring a range of health statuses.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 3 to 18 years with ASA physical classification I, II, or III scheduled for strabismus surgery.
Not a fit: Patients with underlying cardiovascular disease, conduction disturbances, or neuromuscular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer surgical outcomes and reduced complications for children undergoing strabismus surgery.
How similar studies have performed: While the specific approach of deep neuromuscular blockade in strabismus surgery is not widely tested, similar techniques in other surgical contexts have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Strabismus