Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Emergence Delirium Clinical Trial

Official title:

Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263844
• Other study ID #: IndonesiaUAnes 051
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2019
• Est. completion date: October 10, 2019

Study information

• Verified date: February 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Drug:
• Intranasal dexmedetomidine
subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction
• Intranasal Midazolam
subject will receive premedication with intranasal midazolam thirty minutes before induction

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & 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. — View 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. Review. — View 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. — View 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 — View 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. — View Citation

Silva LM, Braz LG, Módolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of emergence delirium thirty minutes after surgery	PAED score was measured	30 minutes