Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2019-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Intranasal dexmedetomidine

Intervention Type DRUG

subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction

Midazolam

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

Group Type ACTIVE_COMPARATOR

Intranasal Midazolam

Intervention Type DRUG

subject will receive premedication with intranasal midazolam thirty minutes before induction

Interventions

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Intranasal dexmedetomidine

subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction

Intervention Type DRUG

Intranasal Midazolam

subject will receive premedication with intranasal midazolam thirty minutes before induction

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No