Effect of Intranasal Dexmedetomidine on the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorAlexandria University

About this trial

Dexmedetomidine is a selective a-2 adrenergic agonist that provides sedative and analgesic effects. Intranasal dexmedetomidine has a slower and gradual onset compared to intravenous injection , with low incidence of nasal discomfort. Dexmedetomidine was tested at various doses and modes of administration, as well as different types of surgery and co-anesthetic drugs, as a single injection or continuous infusion. The authors have not agreed on the ideal clinical dose. The hypothesis is that intranasal dexmedetomidine 3mcg /kg will decrease the incidence of emergence agitation after strabismus surgery than dexmedetomidine 2 mcg/kg

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 3-6 years, both sexes

ASA physical status class I , II.

Disqualifiers

history of neurological and psychiatric disease

body mass index > 20 kg m-2

allergy to dexmedetomidine

patients on medical treatment which has any sedative effect

Trial design

Design model

Parallel

Treatments tested in this trial

  • high dex group

    Other intervention

    patients will receive 3 mcg/kg intranasal dexmedetomidine 45minutes before surgery

  • low dex group

    Other intervention

    patients will receive 2 mcg/kg intranasal dexmedetomidine 45minutes before surgery

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: high dex groupOther 1 intervention
Group B: low dex groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of emergence agitation

pediatric anesthesia emergence delirium ( PAED) scale.

Time frame
postoperative day 1

Secondary outcomes

1

Incidence of intraoperative hemodynamic changes

bradycardia and hypotension

Time frame
postoperative day 1
2

Modified Yale Preoperative Anxiety Scale (mYPAS) upon separation from parents

mYPAS

Time frame
postoperative day1
3

PACU discharge time

minutes

Time frame
postoperative day 1

Other outcomes

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