Monitoring sedation depth in children during anesthesia for laryngoscopy
Official title: Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures
Run by University Hospital, Antwerp · NCT03426579 · Data updated 2026-11-12
This study tests a new monitor to see if it can help doctors better manage anesthesia levels in children during throat procedures to keep them safe and comfortable.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Month to 8 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Status | Recruiting |
| Started | October 23, 2017 |
| Main results expected | October 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | January 22, 2025 |
| Trial ID | NCT03426579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children scheduled for elective direct laryngoscopy with surgical intervention whose parents or legal guardians can provide informed consent.
✕Probably not a fit
Patients who refuse informed consent or have known allergies to dexmedetomidine or remifentanil will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates how well the NeuroSENSE ® NS 701 Monitor correlates with reflexes during intravenous anesthesia in children undergoing direct laryngoscopy. It aims to improve sedation management by preventing under- or over-sedation through real-time monitoring of sedation depth. The monitor uses electroencephalogram quantification to provide a sedation depth index, which is crucial for adjusting anesthesia levels based on individual patient needs. The study focuses on children, a population at higher risk for complications related to anesthesia.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anesthesia in children undergoing surgical procedures.
How similar studies have gone: While the NeuroSENSE monitor has been validated for adults, its application in children is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: scheduled for elective direct laryngoscopy with surgical intervention, written informed consent of their parents or legal guardian. Exclusion Criteria: refusal of informed consent, known allergy for dexmedetomidine or remifentanil at start of anesthesia pulse oxygen saturation (SaO2) lower than 85%
Where it's running
-
University hospital Antwerp
Edegem, Antwerp, Belgium Recruiting
Study contacts
- Principal investigator: Vera Saldien — University Hospital, Antwerp
- Study coordinator: Vera Saldien, MD
- Email: vera.saldien@uza.be
- Phone: 38214788
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.