Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

• Status: Completed
• Trial end date: 2019-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Dexmedetomidine; Midazolam

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