N/A
N=45
Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery
Strabismus · Reflex, Oculocardiac · Hydroxyzine · Bradycardia Sinus
Bottom Line
View on ClinicalTrials.gov: NCT03806270 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Heart Rate-1 — 114.4; 125.8; 122.3 beats per minute
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Midazolam (Drug); Hydroxyzine Dihydrochloride (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Yeditepe University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate-1 |
114.4; 125.8; 122.3 | — |
| PRIMARY Heart Rate-2 |
110.4; 125.3; 124.8 | — |
| PRIMARY Heart Rate-3 |
90.8; 113.4; 117.9 | — |
| PRIMARY Number of Observed Oculocardiac Reflex(OCR) |
15; 6; 1 | — |
| SECONDARY Ramsay Sedation Score |
2; 0; 2; 13; 15; 9 | — |
Summary
Oculocardiac reflex (OCR) is usually happening in pediatric strabismus surgery and observed just when the surgent pulls the ocular muscles. The reflex is one of the trigemino-vagal reflexes, and causes bradycardia, arrhythmia, and even cardiac arrest during eye surgery.
Premedication for relaxation with drugs like hydroxyzine dihydrochloride or midazolam before surgery of the pediatric population is often used in Turkey, although it is not recommended in foreign countries. Some recent studies showed that when midazolam and hydroxyzine dihydrochloride used together not only, they lessen agitation before surgery but also they prevent emergence agitation.
The primary aim of this prospective observational study is to show the effect of hydroxyzine dihydrochloride on preventing the pediatric patient from Oculocardiac reflex related to strabismus surgery.
Eligibility Criteria
Inclusion Criteria
- Strabismus, surgery needed
- Esotropia, surgery needed
Exclusion Criteria
- Chronic disease
- Arrhythmia
- Glaucoma(narrow-angle)
Data sourced from ClinicalTrials.gov (NCT03806270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.