RecruitingNCT03426579

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


Sponsor

University Hospital, Antwerp

Enrollment

10 participants

Start Date

Oct 23, 2017

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 MonthMax Age: 8 Years

Inclusion Criteria1

  • scheduled for elective direct laryngoscopy with surgical intervention, written informed consent of their parents or legal guardian.

Exclusion Criteria1

  • refusal of informed consent, known allergy for dexmedetomidine or remifentanil at start of anesthesia pulse oxygen saturation (SaO2) lower than 85%

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Interventions

DEVICENeuroSENSE ®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.


Locations(1)

University hospital Antwerp

Edegem, Antwerp, Belgium

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NCT03426579


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