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Recruiting NCT03426579

NCT03426579 Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures

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Clinical Trial Summary
NCT ID NCT03426579
Status Recruiting
Phase
Sponsor University Hospital, Antwerp
Condition Laryngoscopy
Study Type OBSERVATIONAL
Enrollment 10 participants
Start Date 2017-10-23
Primary Completion 2025-10-30

Eligibility & Interventions

Sex All sexes
Min Age 1 Month
Max Age 8 Years
Study Type OBSERVATIONAL
Interventions
NeuroSENSE ®in children

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 10 participants in total. It began in 2017-10-23 with a primary completion date of 2025-10-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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%

Contact & Investigator

Central Contact

Vera Saldien, MD

✉ vera.saldien@uza.be

📞 38214788

Principal Investigator

Vera Saldien

PRINCIPAL INVESTIGATOR

University Hospital, Antwerp

Frequently Asked Questions

Who can join the NCT03426579 clinical trial?

This trial is open to participants of all sexes, aged 1 Month or older, up to 8 Years, studying Laryngoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03426579 currently recruiting?

Yes, NCT03426579 is actively recruiting participants. Contact the research team at vera.saldien@uza.be for enrollment information.

Where is the NCT03426579 trial being conducted?

This trial is being conducted at Edegem, Belgium.

Who is sponsoring the NCT03426579 clinical trial?

NCT03426579 is sponsored by University Hospital, Antwerp. The principal investigator is Vera Saldien at University Hospital, Antwerp. The trial plans to enroll 10 participants.

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