Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

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.

Completed

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal dexmedetomidine

Drug

subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction

Intranasal midazolam

Drug

subject will receive premedication with intranasal midazolam thirty minutes before induction

Primary outcomes

incidence of emergence delirium thirty minutes after surgery

Time frame: 30 minutes

PAED score was measured

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Feb 11, 2020
Registry last updated: Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed