Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Phase 4

Completed

• Conditions: Emergence Delirium
• Interventions: Drug: Intranasal Midazolam; Drug: Intranasal dexmedetomidine

• Registration Number: NCT04263844
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Status Verified: 2020-02
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Intranasal Midazolam	subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction
Dexmedetomidine	Intranasal dexmedetomidine	subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction

Primary Outcome Measures

Name	Time	Method
incidence of emergence delirium thirty minutes after surgery	30 minutes	PAED score was measured

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia