Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention
Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedFebruary 12, 2020
February 1, 2020
9 months
February 7, 2020
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of emergence delirium thirty minutes after surgery
PAED score was measured
30 minutes
Study Arms (2)
Dexmedetomidine
ACTIVE COMPARATORsubject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction
Midazolam
ACTIVE COMPARATORsubject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction
Interventions
subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction
subject will receive premedication with intranasal midazolam thirty minutes before induction
Eligibility Criteria
You may qualify if:
- children undergoing ophthalmologic surgery with general anesthesia
- children aged 1 - 12 years old
- physical status ASA 1-2
- signing informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430, Indonesia
Related Publications (6)
Cohen MM, Cameron CB, Duncan PG. Pediatric anesthesia morbidity and mortality in the perioperative period. Anesth Analg. 1990 Feb;70(2):160-7. doi: 10.1213/00000539-199002000-00005.
PMID: 2301747RESULTMohkamkar 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.
PMID: 25535538RESULTKim 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.
PMID: 21390159RESULTSilva 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.
PMID: 18372935RESULTKey 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.
PMID: 21309294RESULTLee 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.
PMID: 20740210RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andi Ade W Ramlan
Indonesia University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Pediatric Anesthesia Division
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 11, 2020
Study Start
January 10, 2019
Primary Completion
October 10, 2019
Study Completion
October 10, 2019
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share