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Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

NCT04263844 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-02-12

No results posted yet for this study

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.

Conditions

  • Emergence Delirium

Interventions

DRUG

Intranasal dexmedetomidine

subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction

DRUG

Intranasal Midazolam

subject will receive premedication with intranasal midazolam thirty minutes before induction

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Andi Ade W Ramlan · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2019-10-10
Completion
2019-10-10

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04263844 on ClinicalTrials.gov