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Recruiting Observational

Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures

NCT03426579 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2017-10-23
Last updated
2025-01-22

Condition(s) studied

LaryngoscopyChildMonitoring

Investigational drug(s) / intervention(s)

NeuroSENSE ®in children

NeuroSENSE ®in children: Before induction of anesthesia NeuroSENSE ® monitoring will be applied to all subjects.General anesthesia with dexmedetomidine and remifentanil is titrated based on the evaluation of respiratory clinical signs (cough, spasm, movement) and immobility of the vocal cords. The anesthesiologist performing anesthesia will be blinded for the Wavelet-based Anesthetic Value for Central Venous System (WAVCNS) index assessed by NeuroSENSE ® and will adjust dexmedetomidine according to clinical signs, which is standard of care. Retrospectively data obtained by NeuroSENSE ® will be compared to evaluate whether they are useful in predicting upcoming unwanted airway reflexes.

Study summary

This study evaluates the correlation between sedation depth monitoring obtained by NeuroSENSE ® NS 701 Monitor and reflexes during intravenous anesthesia in children undergoing direct laryngoscopy for surgical procedures.

Eligibility

Sex
ALL
Min age
1 Month
Max age
8 Years
Healthy volunteers
No
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%

Primary outcome measure(s)

  • predictability of NeuroSENSE ® in upcoming unwanted airway reflexes — during surgery
    Define whether the NeuroSENSE ® provides information before upcoming clinical signs about under- or over-sedation defined as cough, laryngospasm, apnea or desaturation

Trial sites (1)

FacilityCityRegionStatus
University hospital Antwerp Edegem Antwerp Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03426579 on ClinicalTrials.gov ↗ ← All trials in Belgium