Epilepsy Clinical Trial
— MeloDexOfficial title:
Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children
Verified date | November 2022 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | October 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 20 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Children that were unable to follow the study protocol were excluded during the study |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Comparison of the three medical interventions on respiratory rate | Measurement of respiratory rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study. | During the intervention | |
Secondary | Comparison of the three medical interventions on heart rate | Measurement of heart rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study. | During the intervention | |
Secondary | Comparison of the three medical interventions on oxygene saturation | Measurement of oxygene saturation using pulse oximetry every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study. | During the intervention | |
Secondary | Comparison of the three medical interventions on blood pressure | Measurement of systolic and diastolic blood pressure will be noted at the time of application of the medicine, at the end of EEG and after 120 minutes. These values will be compared across the three arms of the study. | During the intervention |
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