About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
children scheduled for direct laryngoscopy with surgical intervention
Trial design
Cohort
Prospective
Treatments tested in this trial
NeuroSENSE ®in children
DeviceBefore 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.
Treatment groups
Trial outcomes
Primary outcomes
predictability of NeuroSENSE ® in upcoming unwanted airway reflexes
Define whether the NeuroSENSE ® provides information before upcoming clinical signs about under- or over-sedation defined as cough, laryngospasm, apnea or desaturation
Secondary outcomes
Incidence of leg movement
Incidence of any lower limb movement during anesthesia
Total cumulative dose of dexmedetomidine
Total dose of dexmedetomidine during anesthesia in microgram
Total cumulative dose of remifentanil
Total dose of remifentanil during anesthesia in microgram
Postoperative awaking time
Time between end of surgery and addressability of the patient in minutes
Sponsors and contacts
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