CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
Intranasal dexmedetomidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04263844
NCT04263844Phase 4Completed

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

Indonesia University·interventional·Posted Feb 11, 2020·Updated Feb 12, 2020

In Brief

A Phase 4 clinical trial evaluating Intranasal dexmedetomidine and Intranasal Midazolam for Emergence Delirium. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 11, 2020
Enrollment StartJan 10, 2019
Primary CompletionOct 10, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.4 years ago

Interventions

Intranasal dexmedetomidinedrug

subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction

Intranasal Midazolamdrug

subject will receive premedication with intranasal midazolam thirty minutes before induction