DeliriumNCT04816344
Emergence Delirium in Children for Magnetic Resonance Imaging
An observational study of Delirium and Pediatric Disorder, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Delirium, Pediatric Disorder, Anesthesia
- What is being tested?
- Outpatient Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: children undergoing outpatient anaesthesia for elective MRI under sedation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yıldırım, 16290
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium, Pediatric Disorder, Anesthesia
- Being tested
- Outpatient Anesthesia
- Keywords
- MRI scans, pediatric, delirium, anaesthesia
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient AnesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Outpatient Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence delirium
the incidence of emergence delirium
Measured: until 30 minutes after arrival in the recovery room
Secondary outcomes (1)
adverse events
apnea, falling in saturation, increased secretin, atropine requirement, bradycardia, nausea-vomiting,hiccup
Measured: up to 1 hour after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jul 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derya Karasu, MD, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Derya Karasu, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816344
- Sponsor's protocol ID
- U1111-1265-0994
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Emergence Delirium in Children Undergoing Outpatient Anaesthesia for Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04816344
- Acronym / sponsor ID
- U1111-1265-0994
- Conditions
- Delirium, Pediatric Disorder, Anesthesia
- Keywords
- MRI scans, pediatric, delirium, anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group MP (n=35) | – | Procedure: Outpatient AnesthesiaThe 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. |
| Group MK (n=35) | – | Procedure: Outpatient AnesthesiaPremedication 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. |
| Group DP (n=35) | – | Procedure: Outpatient AnesthesiaPremedication 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. |
| Group DK (n=35) | – | Procedure: Outpatient AnesthesiaPremedication 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. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children undergoing outpatient anaesthesia for elective MRI under sedation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- difficult airway,
- allergies to the study drugs,
- asthma,
- severe central nervous system disease (eg, brain tumour, uncontrolled seizures),
- mental motor retardation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient AnesthesiaThe 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. | Procedure or surgery | Group DK (n=35), Group DP (n=35), Group MK (n=35), Group MP (n=35) |
Primary outcome
emergence delirium
Time frame: until 30 minutes after arrival in the recovery room
the incidence of emergence delirium
1 secondary outcome
adverse events
Time frame: up to 1 hour after anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Karasu principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Pediatric Disorder, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emergence delirium (time frame: until 30 minutes after arrival in the recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.