N/A
Completed N=45
Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery
Strabismus · Reflex, Oculocardiac · Hydroxyzine · Bradycardia Sinus
Source: ClinicalTrials.gov NCT03806270 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Heart Rate-1 — 114.4; 125.8; 122.3 beats per minute
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.
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 | — |
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. Informational only — not medical advice.