Clinical trial NCT04263844: Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention
Official title: Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergence Delirium
Keywords: emergence, delirium, dexmedetomidine, midazolam, pediatric
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: incidence of emergence delirium thirty minutes after surgery
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Andi Ade W Ramlan
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.
citation: Kim JH. Mechanism of emergence agitation induced by sevoflurane anesthesia. Korean J Anesthesiol. 2011 Feb;60(2):73-4. doi: 10.4097/kjae.2011.60.2.73. Epub 2011 Feb 25. No abstract available.
citation: Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
citation: Key KL, Rich C, DeCristofaro C, Collins S. Use of propofol and emergence agitation in children: a literature review. AANA J. 2010 Dec;78(6):468-73.
citation: Lee CJ, Lee SE, Oh MK, Shin CM, Kim YJ, Choe YK, Cheong SH, Lee KM, Lee JH, Lim SH, Kim YH, Cho KR. The effect of propofol on emergence agitation in children receiving sevoflurane for adenotonsillectomy. Korean J Anesthesiol. 2010 Aug;59(2):75-81. doi: 10.4097/kjae.2010.59.2.75. Epub 2010 Aug 20.