Oculocardiac Reflex, Premedication
Conditions
Keywords
dexmedetomidine, intranasal, strabismus surgery, premedication, oculocardiac reflex
Brief summary
The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.
Detailed description
Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.
Interventions
DRUGDexmedetomidine
via intranasal route 1 mcg/kg
DRUGKetamine
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* the pediatric patients undergoing strabismus surgery * the pediatric patients between 2-11 years old * ASA physical status I-II * the patients whose parents give permission for this study
Exclusion criteria
* a known drud allergy or hypersensitive reaction to drugs used * mental retardation * cardiac arrhythmia or congenital cardiac disease * organ disfunction (liver , kidney) * nasal pathology * psychotropic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the efficacy of premedication on ramsey sedation score | 30 min after premedication | after drug administration ramsey sedation scale is evaluate every 5 min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the effects of premedication on oculocardiac reflex | during the surgery | the heart rate drops the 20% of the resting rate |
| mask acceptance scale | 30 min after sedation | The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale. |
| the parenteral separation anxiety scale | 30 min after sedation | The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min. |
Countries
Turkey (Türkiye)
Outcome results
None listed