Emergence Delirium in Children for Magnetic Resonance Imaging

The Frequency of Emergence Delirium in Children Undergoing Outpatient Anaesthesia for Magnetic Resonance Imaging

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Anesthesia; Pediatric Disorder
• Intervention / Treatment: Procedure: Outpatient Anesthesia

Detailed Description

This was a prospective, observational, and single-center study conducted between July-November 2018. The study protocol was approved by the Local Ethics Committee. The study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from the parent.

The patients were separated into four groups according to the anaesthetic agents given.Intranasal premedication was applied to all the patients, then an intravenous cannula was placed and the anaesthetic agents were administered intravenously. The Ramsay Sedation Scale (RSS) was used to evaluate the level of sedation, with a target of 5 points. The RSS is scored from 1-6 as follows: 1: the patient is worried and anxious, or restless, 2: the patient is calm and co-operative, and can be directed, 3: the patient only responds to instructions, 4: the patient responds rapidly to painful stimuli, 5: the patient demonstrates a slow response to painful stimuli, 6: the patient does not respond. When RSS 5 was reached following the first bolus dose of the drug, an additional dose was administered. When RSS 5 was obtained and hemodynamic stability was ensured, the patient was placed on the MRI table.

The patient was monitored in the recovery room for regaining consciousness for up to 30 mins after the procedure. AED was evaluated using the PAED scale by a nurse trained in the use of this scale. PAED scoring was repeated every 5 mins until the patient was discharged from the recovery room. If the PAED score was ≥10, a diagnosis of AED was made. Adverse events such as laryngospasm, desaturation (SpO2 <95%), respiratory depression, bradycardia, allergy, hiccoughs, nystagmus, nausea, and vomiting were recorded. When a Modified Aldrete Score of >9 was obtained, the child was observed for a further 15 mins then transferred from the recovery room.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Turkey
  • Yıldırım
    • Bursa, Yıldırım, Turkey, 16290
      • University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children undergoing outpatient anaesthesia for elective MRI under sedation

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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 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; 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); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergence delirium	the incidence of emergence delirium	until 30 minutes after arrival in the recovery room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	apnea, falling in saturation, increased secretin, atropine requirement, bradycardia, nausea-vomiting,hiccup	up to 1 hour after anesthesia

Collaborators and Investigators

• Sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
• Investigators: Principal Investigator: Derya Karasu, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: delirium; pediatric; anaesthesia; MRI scans
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: U1111-1265-0994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No