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Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery

NCT03806270 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2019-10-22

Study results available
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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.

Conditions

  • Strabismus
  • Reflex, Oculocardiac
  • Hydroxyzine
  • Bradycardia Sinus

Interventions

DRUG

Midazolam

Demizolam 15mg/ml ampules, given orally with cherry juice

DRUG

Hydroxyzine Dihydrochloride

Atarax 2mg/ml syrup, given orally

Sponsors & Collaborators

  • Yeditepe University

    lead OTHER

Principal Investigators

  • Ferda F Kartufan, Assist.Prof · Yeditepe University Hospital

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-02-15
Completion
2019-02-15
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806270 on ClinicalTrials.gov