Actively Recruiting
Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures
Led by University Hospital, Antwerp · Updated on 2025-01-22
10
Participants Needed
1
Research Sites
427 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well the NeuroSENSE NS 701 Monitor, a device that measures sedation depth using brain activity, can predict unwanted airway reflexes during intravenous anesthesia in children undergoing direct laryngoscopy for surgery. The study focuses on children from about 1 month to 8 years old. Dexmedetomidine and remifentanil are commonly used sedatives adjusted based on observing respiratory signs and vocal cord movement, but NeuroSENSE provides an automated measure that might help improve sedation management in children, who are at risk of over- or under-sedation. In this study, the NeuroSENSE monitor is attached before anesthesia induction but the anesthesiologist is blinded to its readings and titrates dexmedetomidine and remifentanil using usual clinical signs. Anesthesia starts with sevoflurane and a dexmedetomidine bolus, followed by continuous infusion adjusted as needed. Remifentanil is also infused and adjusted similarly. Before surgery, lidocaine spray is applied to anesthetize the vocal cords, and oxygen is given through a pharyngeal tube while maintaining spontaneous breathing. If laryngospasm or oxygen desaturation occurs, propofol is used as rescue medication. During and after surgery, heart rate, blood pressure, oxygen saturation, and breathing rate are monitored. Researchers will assess events like leg movements, cough, awakening time, and recovery. Surgery satisfaction is rated on a scale from 1 to 3. Total doses of sedatives are recorded, and NeuroSENSE data are analyzed retrospectively to see if the device helps predict airway reflexes. After surgery, children are closely monitored in intensive care or post-anesthetic care units as part of standard care.
CONDITIONS
Official Title
Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for elective direct laryngoscopy with surgical intervention
- Written informed consent from parents or legal guardian
You will not qualify if you...
- Refusal of informed consent
- Known allergy to dexmedetomidine or remifentanil at anesthesia start
- Pulse oxygen saturation (SaO2) lower than 85%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
V
Vera Saldien, MD
J
Joke De Wachter
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here