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Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Primary Purpose

Emergence Delirium

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Intranasal dexmedetomidine
Intranasal Midazolam
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring emergence, delirium, dexmedetomidine, midazolam, pediatric

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo Cental National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine

Midazolam

Arm Description

subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction

subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction

Outcomes

Primary Outcome Measures

incidence of emergence delirium thirty minutes after surgery
PAED score was measured

Secondary Outcome Measures

Full Information

First Posted
February 7, 2020
Last Updated
February 10, 2020
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04263844
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
Keywords
emergence, delirium, dexmedetomidine, midazolam, pediatric

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction
Intervention Type
Drug
Intervention Name(s)
Intranasal dexmedetomidine
Intervention Description
subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction
Intervention Type
Drug
Intervention Name(s)
Intranasal Midazolam
Intervention Description
subject will receive premedication with intranasal midazolam thirty minutes before induction
Primary Outcome Measure Information:
Title
incidence of emergence delirium thirty minutes after surgery
Description
PAED score was measured
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andi Ade W Ramlan
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2301747
Citation
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 Reference
result
PubMed Identifier
25535538
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.
Results Reference
result
PubMed Identifier
21390159
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.
Results Reference
result
PubMed Identifier
18372935
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.
Results Reference
result
PubMed Identifier
21309294
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.
Results Reference
result
PubMed Identifier
20740210
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.
Results Reference
result

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Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

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