Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

NCT04665453 | Completed DMC

• 1 other identifier: 0120-597/2019/16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.

Conditions

Electroencephalography; Child; Dexmedetomidine; Melatonin; Sleep; Epilepsy

Keywords

Child; Dexmedetomidine; Melatonin; Electroencephalography; Autism Spectrum Disorder; Developmental Delay Disorder; Epilepsy; Sleep; Sleep induction

Outcome Measures

Primary Outcomes (2)

• Comparison of the three medical interventions on sleep initiation

  The time-interval between the drug application and time of sleep initiation will be recorded in minutes. These values will be compared across the three arms of the study

  During the intervention

• Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG

  During EEG in sleep, which will be recorderd using a standard 10-20 placement with additional electrodes for breathing and ECG, the EEG background activity will be evaluated for the deepest sleep stage according to the standard EEG classification (Carskadon MA, Dement WC. Normal Human Sleep: an Overview. In: Kryger M, Roth T, Dement WC. Principles and practice of sleep medicine. St.Louis: Saunders/Elsevier, 2011:16-26.). Also, the sleep stage in which the patient will spend the most time will be noted. These values will be compared across the three arms of the study.

  During the intervention

Secondary Outcomes (4)

• Comparison of the three medical interventions on respiratory rate

  During the intervention

• Comparison of the three medical interventions on heart rate

  During the intervention

• Comparison of the three medical interventions on oxygene saturation

  During the intervention

• Comparison of the three medical interventions on blood pressure

  During the intervention

Study Arms (3)

Melatonin peroral

EXPERIMENTAL

0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring

Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Melatonin 0,1mg/kg oral syrup

Dexmedetomidine intranasally

EXPERIMENTAL

3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring

Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Dexmedetomidine 3 mcg/kg intranasally

Dexmedetomidine sublingually

EXPERIMENTAL

3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring

Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Dexmedetomidine 3 mcg/kg sublingually

Interventions

Electroencephalography DIAGNOSTIC_TEST

Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated

Also known as: EEG

Dexmedetomidine intranasally; Dexmedetomidine sublingually; Melatonin peroral

Monitoring of vital functions DIAGNOSTIC_TEST

Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.

Dexmedetomidine intranasally; Dexmedetomidine sublingually; Melatonin peroral

Melatonin 0,1mg/kg oral syrup DRUG

Melatonine in the form of syrup will be given orally to child.

Melatonin peroral

Dexmedetomidine 3 mcg/kg sublingually DRUG

Dexmedetomidine in the form of a solution will be given to child sublingually.

Dexmedetomidine sublingually

Dexmedetomidine 3 mcg/kg intranasally DRUG

Dexmedetomidine in the form of nasal spray will be given to child intranasally.

Dexmedetomidine intranasally

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 1 and 20 years
• Referral for EEG in sleep
• Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form

You may not qualify if:

• Children that were unable to follow the study protocol were excluded during the study

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Peganc Nuncic K, Neubauer D, Orazem Mrak J, Perkovic Benedik M, Mahne U, Bizjak N, Rener Primec Z, Sustar N, Butenko T, Vrscaj E, Osredkar D. Melatonin vs. dexmedetomidine for sleep induction in children before electroencephalography. Front Pediatr. 2024 Apr 25;12:1362918. doi: 10.3389/fped.2024.1362918. eCollection 2024.

  PMID: 38725985 DERIVED

MeSH Terms

Conditions

Epilepsy; Autism Spectrum Disorder; Developmental Disabilities

Interventions

Electroencephalography; Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Damjan Osredkar, MD, PhD

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 11, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)