drugset / Trial / NCT04263844
Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2019-01-10
- Primary completion
- 2019-10-10
- Completion
- 2019-10-10
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexmedetomidine | Other / unclassified | 1 ug/kg | Intranasal |
| Comparator | Midazolam | Small molecule | 0.1 mg/kg | Intranasal |