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Efficacy of Dexmedetomidine on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Double-Blind Randomized Controlled Trial with Heart Rate Variability and Electroencephalography-Guided Anesthesia
EU CTIS ID: 2025-524086-24-00
What this study is testing
To evaluate if dexmedetomidine reduces the risk of emergence delirium in children aged 1-7 years old undergoing adenotonsillectomy during general anesthesia guided by heart rate variability and electroencephalogram monitoring.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- American Society of Anesthesiologists I and II
- Children aged 1–7 years
- Scheduled to undergo adenotonsillectomy
You likely can't join if
- Known allergies or intolerances to Dexmedetomidine
- Acute cerebrovascular conditions
- Clinically unfit for general anesthesia
- Neuropsychiatric diagnoses that include: intellectual disabilities, disorders of psychological development, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence. As defined in ICD-10, F70 to F98.
- Daily use of analgesics
- Under investigation for a neuropsychiatric diagnosis as defined in exclusion point number 3.
See the full eligibility criteria
- American Society of Anesthesiologists I and II
- Children aged 1–7 years
- Scheduled to undergo adenotonsillectomy
- Known allergies or intolerances to Dexmedetomidine
- Acute cerebrovascular conditions
- Clinically unfit for general anesthesia
- Neuropsychiatric diagnoses that include: intellectual disabilities, disorders of psychological development, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence. As defined in ICD-10, F70 to F98.
- Daily use of analgesics
- Under investigation for a neuropsychiatric diagnosis as defined in exclusion point number 3.
- Children whose legally authorized representative does not speak and read sufficient Norwegian or English.
- Missing consent from the participant’s legally authorized representatives
- Second- or third-degree atrioventricular block, unless the patient has a pacemaker.
- Uncontrolled hypotension
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.