Clinical trial Recruiting at 1 site Observational Ages 1 Month to 8

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 typeObservational
Ages1 Month to 8 Years
SexAll
Enrollment10 (estimated)
SponsorUniversity Hospital, Antwerp
Academic / other
Locations1 site (Edegem, Antwerp)
StatusRecruiting
StartedOctober 23, 2017
Main results expectedOctober 30, 2025
Study endsDecember 31, 2025
Registry record updatedJanuary 22, 2025
Trial IDNCT03426579 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.