Comparison of Dexmedetomidine and Midazolam for Prevention of Emergence Delirium in Children

NCT03337672 | Completed

• 1 other identifier: 2017-04-038-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence delirium is a common complication in children after anesthesia. The incidence of emergence delirium is reported upto 50%. Prevention of emergence delirium in children is important not only for the patient safety but also for the satisfaction of the parents. Midazolam is the most commonly used medications for prevention of emergence delirium. However, it might lead to delayed awakening from anesthesia and respiratory depression. In this study, the investigators will evaluate whether dexmedetomidine can be effectively and safely administered for prevention of emergence delirium in children compared to midazolam.

Conditions

Tonsillitis

Outcome Measures

Primary Outcomes (1)

• Presence of Emergence Delirium (ED)

  During the PACU stay, the patients will be assessed whether the emergence delirium (ED) occurred. It is defined as ED, if the highest score is more than 3 points after five time point measurements by the four-point agitation scale (1=calm, 2=not calm but easily calmed, 3=not easily calmed, moderately agitated, and 4=combative, excited, disoriented). The five time points are the 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU.

  0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU

Secondary Outcomes (2)

• Severity of Emergence Delirium

  10 minutes after arrival at the PACU

• Emergence time

  3 minutes after extubation

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Subjects who receive dexmedetomidine for prevention of emergence delirium

Drug: Dexmedetomidine

Midazolam group

ACTIVE COMPARATOR

Subjects who receive midazolam for prevention of emergence delirium

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery

Dexmedetomidine group

Midazolam DRUG

Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery

Midazolam group

Eligibility Criteria

• Age: 24 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients undergoing elective tonsillectomy under general anesthesia
• American society of anesthesiologist physical status 1,2
• aged from 24 months to 12 years old
• obtaining written informed consent

You may not qualify if:

• known history of allergy to dexmedetomidine or midazolam
• renal impairment
• hepatic impairment
• long QT syndrome
• developmental disorder
• congenital disorder
• neurologic disorder
• psychogenic disorder

Sponsors & Collaborators

• Eunah Cho, MD: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Tonsillitis

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eunah Cho, M.D.

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 9, 2017
• Study Start: December 5, 2017
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

KR (1)