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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-8
SponsorUniversity Hospital, Antwerp

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial population

children scheduled for direct laryngoscopy with surgical intervention

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NeuroSENSE ®in children

    Device

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Reliability of NeuroSENSE ®in children1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
during surgery

Secondary outcomes

1

Incidence of leg movement

Incidence of any lower limb movement during anesthesia

Time frame
During surgery
2

Total cumulative dose of dexmedetomidine

Total dose of dexmedetomidine during anesthesia in microgram

Time frame
From induction of anesthesia till extubation with a maximum up to 4 hours after intubation
3

Total cumulative dose of remifentanil

Total dose of remifentanil during anesthesia in microgram

Time frame
From induction of anesthesia till extubation with a maximum up to 4 hours after intubation
4

Postoperative awaking time

Time between end of surgery and addressability of the patient in minutes

Time frame
Time between end of surgery and opening of the eyes in minutes, up to a maximum of 30 minutes

Other outcomes

Sponsors and contacts

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