Emergence Delirium in Children for Magnetic Resonance Imaging

NCT04816344 | Completed

• 1 other identifier: U1111-1265-0994
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Sedation or anaesthesia is necessary to be able to perform magnetic resonance imaging (MRI) on children who cannot keep still or are uncooperative, and thus the targets of maximum patient safety, successful imaging, and the highest imaging quality can be achieved. There are various drugs for sedation in MRI. A child with Anaesthesia Emergence Delirium (AED) has a state of consciousness which can be described as "irritable, uncompromising, inconsistent, crying inconsistently, wailing, and kicking". The incidence of AED worldwide has been reported to vary between 18% and 80%, depending on the diagnostic criteria used. This difference can usually be explained by the use of different scales and defining criteria. In 2004, Sikich and Lerman developed the Paediatric Anaesthesia Emergence Delirium (PAED) scale, including cognitive evaluation components in addition to agitation behaviours, and the validity and reliability of this scale have been proven. In a study of anaesthesia early delirium in children by Bong et al.7 a score of ≥10 on the PAED scale was shown to have the greatest sensitivity and specificity for the diagnosis of anaesthesia early delirium. The aim of this study was to investigate the effect on the occurrence of emergence delirium, and recovery, of propofol and ketofol in paediatric patients undergoing diagnostic MRI following premedication with intranasal dexmedetomidine and midazolam.

Conditions

Delirium; Pediatric Disorder; Anesthesia

Keywords

MRI scans; pediatric; delirium; anaesthesia

Outcome Measures

Primary Outcomes (1)

• emergence delirium

  the incidence of emergence delirium

  until 30 minutes after arrival in the recovery room

Secondary Outcomes (1)

• adverse events

  up to 1 hour after anesthesia

Study Arms (4)

Group MP (n=35)

The patients were separated into four groups according to the anaesthetic agents given. Premedication was applied as intranasal 0.2 mg/kg midazolam, then 1 mg/kg of propofol iv bolus as an anaesthetic agent was administered, and if necessary propofol 0.5 mg/kg iv was given as additional dosage.

Procedure: Outpatient Anesthesia

Group MK (n=35)

Premedication was applied as intranasal 0.2 mg/kg midazolam, then 1 mg/kg ketofol (10% ketamine + 10% propofol) iv bolus as an anaesthetic agent was administered, and if necessary 0.5 mg/kg iv ketofol was given as additional dosage.

Procedure: Outpatient Anesthesia

Group DP (n=35)

Premedication was applied as intranasal 1 mcg/kg dexmedetomidine, then 1 mg/kg of propofol iv bolus as an anaesthetic agent was administered, and if necessary propofol 0.5 mg/kg iv was given as additional dosage.

Procedure: Outpatient Anesthesia

Group DK (n=35)

Premedication was applied as intranasal 1 mcg/kg dexmedetomidine, then 1 mg/kg ketofol iv bolus as an anaesthetic agent was administered, and if necessary 0.5 mg/kg ketofol iv was given as an additional dosage.

Procedure: Outpatient Anesthesia

Interventions

Outpatient Anesthesia PROCEDURE

The inclusion criteria were children aged between 2 and 10 years, undergoing outpatient anaesthesia for elective MRI under sedation, and classified as American Society of Anesthesiologists (ASA) grade I-II. The study exclusion criteria were defined as difficult airway, allergies to the study drugs, asthma, severe central nervous system disease (eg, brain tumour, uncontrolled seizures), mental motor retardation, the application of another procedure after MRI sedation, and those whose parents declined to participate in the study.

Group DK (n=35); Group DP (n=35); Group MK (n=35); Group MP (n=35)

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children undergoing outpatient anaesthesia for elective MRI under sedation

You may qualify if:

• children aged between 2 and 10 years,
• undergoing outpatient anaesthesia for elective MRI under sedation,
• classified as American Society of Anesthesiologists (ASA) grade I-II.

You may not qualify if:

• difficult airway,
• allergies to the study drugs,
• asthma,
• severe central nervous system disease (eg, brain tumour, uncontrolled seizures),
• mental motor retardation,
• the application of another procedure after MRI sedation,
• whose parents declined to participate in the study.

Sponsors & Collaborators

• Turkiye Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, 16290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Derya Karasu

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: July 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

TU (1)