Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03799783
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2019-01-03
Brief Title:
The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders
Sponsor:
Azienda Ospedaliera di Padova
Organization:
Azienda Ospedaliera di Padova
Study Overview
Official Title:
The Use of Dexmedetomidine for Procedural Sedation During EEG in Children Affected by Behavioural Disorders
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Childrens compliance during diagnostic or therapeutic procedures is a challenge often requiring the use of sedative andor analgesic drugs
Electroencephalogram EEG needs stillness for a medium-long period but at the same time the use of any drug for sedation may affect the exam through an interference with EEG waves Dexmedetomidine is a selective 2-adrenergic agonist with sedative and anxiolytic properties with a long effect and which does not alter EEG pattern
The aim of this interventional study is to evaluate the effectiveness safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative
Children affected by behavioral disorders and requiring sedation to perform EEG were considered The protocol establishes to administer IV dexmedetomidine loading dose and continued infusion to reach a targeted level of sedation Pediatric Sedation State Scale 2 Vital signs SatO2 RR EtCO2 HR BP and level of sedation are recorded before during and after procedure until the offset
Electroencephalogram EEG needs stillness for a medium-long period but at the same time the use of any drug for sedation may affect the exam through an interference with EEG waves Dexmedetomidine is a selective 2-adrenergic agonist with sedative and anxiolytic properties with a long effect and which does not alter EEG pattern
The aim of this interventional study is to evaluate the effectiveness safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative
Children affected by behavioral disorders and requiring sedation to perform EEG were considered The protocol establishes to administer IV dexmedetomidine loading dose and continued infusion to reach a targeted level of sedation Pediatric Sedation State Scale 2 Vital signs SatO2 RR EtCO2 HR BP and level of sedation are recorded before during and after procedure until the offset
Detailed Description:
Compliance during diagnostic or therapeutic procedures is a very frequent challenge in children Procedural sedation and analgesia represents an effective answer to this problem Electroencephalogram EEG is a procedure which needs stillness for a medium-long period Whereas the majority of children carry out this procedure without sedation patients with behavioral problems who frequently need to rule out the presence of seizures as associated symptoms or different disease often show an insufficient compliance Sedative drugs usually interfere with EEG cerebral waves pattern so they can not be used Dexmedetomidine is a selective 2-adrenergic agonist with prevalent sedative and anxiolytic properties with a long effect and which does not alter EEG pattern
The aim of this interventional study is to evaluate effectiveness safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative
Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study
The protocol establishes to administer dexmedetomidine IV 2 μgkg in 10 minutes loading dose followed by continuous infusion at a rate of 1 μgkgh until procedure was complete The loading dose can be repeated up to two times if needed to achieve the targeted level of Pediatric Sedation State Scale PSSS of 2 quiet asleep or awake not moving during procedure and no frown or brow furrow indicating pain or anxiety no verbalization of any complaint Vital signs SatO2 RR EtCO2 HR BP and level of sedation are recorded before during and after procedure until the complete awake of the patient The quality of the EEG pattern was also evaluated Occurrence and type of adverse events are registered during this period Finally the caregivers opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered
The aim of this interventional study is to evaluate effectiveness safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative
Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study
The protocol establishes to administer dexmedetomidine IV 2 μgkg in 10 minutes loading dose followed by continuous infusion at a rate of 1 μgkgh until procedure was complete The loading dose can be repeated up to two times if needed to achieve the targeted level of Pediatric Sedation State Scale PSSS of 2 quiet asleep or awake not moving during procedure and no frown or brow furrow indicating pain or anxiety no verbalization of any complaint Vital signs SatO2 RR EtCO2 HR BP and level of sedation are recorded before during and after procedure until the complete awake of the patient The quality of the EEG pattern was also evaluated Occurrence and type of adverse events are registered during this period Finally the caregivers opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None