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

NCT03426579 | Recruiting FDA Device

• 1 other identifier: 17/31/360
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngoscopy; Child; Monitoring

Outcome Measures

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

  during surgery

Secondary Outcomes (4)

• Incidence of leg movement

  During surgery

• Total cumulative dose of dexmedetomidine

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

• Total cumulative dose of remifentanil

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

• Postoperative awaking time

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

Study Arms (1)

Reliability of NeuroSENSE ®in children

Children scheduled for direct laryngoscopy with surgical intervention the reliability of NeuroSENSE ®monitoring will be evaluated

Device: NeuroSENSE ®in children

Interventions

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.

Reliability of NeuroSENSE ®in children

Eligibility Criteria

• Age: 1 Month - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children scheduled for direct laryngoscopy with surgical intervention

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

Study Officials

• Vera Saldien

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Saldien, MD

CONTACT

38214788; vera.saldien@uza.be

Joke De Wachter

CONTACT

328213042; joke.dewachter@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: data manager

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: February 8, 2018
• Study Start: October 23, 2017
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

BE (1)