Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery
Overview
- Phase
- Phase 4
- Intervention
- Intranasal dexmedetomidine
- Conditions
- Emergence Delirium
- Sponsor
- Indonesia University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- incidence of emergence delirium thirty minutes after surgery
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.
Detailed Description
There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.
Investigators
Andi Ade Wijaya Ramlan
Principal Investigator, Pediatric Anesthesia Division
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •children undergoing ophthalmologic surgery with general anesthesia
- •children aged 1 - 12 years old
- •physical status ASA 1-2
- •signing informed consent
Exclusion Criteria
- •children undergoing emergency surgery
- •children with PICU nursing after surgery
- •children with psychological and neurological condition
- •children with allergic history to dexmedetomidine and midazolam
- •children with history of malignant hyperthermia or family history of malignant hyperthermia
- •children with possibility of difficult intubation and ventilation
Arms & Interventions
Dexmedetomidine
subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction
Intervention: Intranasal dexmedetomidine
Midazolam
subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction
Intervention: Intranasal Midazolam
Outcomes
Primary Outcomes
incidence of emergence delirium thirty minutes after surgery
Time Frame: 30 minutes
PAED score was measured