Monitoring sedation depth in children during anesthesia for laryngoscopy
Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 1 Month to 8 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT03426579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children scheduled for elective direct laryngoscopy with surgical intervention whose parents or legal guardians can provide informed consent.
Not a fit: Patients who refuse informed consent or have known allergies to dexmedetomidine or remifentanil will not benefit from this study.
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 performed: While the NeuroSENSE monitor has been validated for adults, its application in children is novel and has not been extensively tested in similar studies.
Eligibility criteria
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 this trial is running
Edegem, Antwerp
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.