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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well the NeuroSENSE 401 Monitor, which measures sedation depth through brain activity, correlates with reflex responses during intravenous anesthesia in children undergoing direct laryngoscopy for surgery. The study focuses on children aged 1 month to 8 years and addresses the challenge of avoiding too much or too little sedation while maintaining spontaneous breathing. Currently, sedation is guided by clinical signs, but the NeuroSENSE monitor may provide earlier information to help adjust anesthesia more precisely. Before anesthesia starts, the NeuroSENSE monitor is set up to record brain activity related to sedation. Children receive general anesthesia with dexmedetomidine and remifentanil, which the anesthesiologist adjusts based on observed respiratory signs like coughing or movement, without seeing the monitor's data. The procedure includes anesthesia induction with sevoflurane and a dexmedetomidine bolus, followed by continuous infusion of dexmedetomidine and remifentanil during surgery. Vocal cords are anesthetized with lidocaine spray, and oxygen is supplied via a pharyngeal tube while spontaneous breathing is maintained. Rescue medication with propofol is available if airway problems occur. Throughout the surgery and afterward, vital signs such as heart rate, blood pressure, oxygen saturation, and breathing rate are continuously recorded. Researchers assess events like leg movements, coughing, and recovery times, as well as satisfaction with the surgery. They also calculate the total dose of anesthetics used. The main goal is to see if the NeuroSENSE monitor can predict unwanted airway reflexes during surgery. After surgery, children are monitored in intensive or post-anesthetic care as usual. The study will gather detailed data to understand sedation depth monitoring in this pediatric setting.
CONDITIONS
Brief 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 parent or legal guardian
- Age between 1 month and 8 years
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 hours during surgery
Participants undergo general anesthesia with dexmedetomidine and remifentanil during direct laryngoscopy. The NeuroSENSE® device monitors sedation depth but anesthesiologists adjust sedation based on clinical signs while blinded to the device data.
1 surgical visit (in-person)
Duration - Up to 30 minutes after surgery
After surgery, participants are monitored in the Intensive Care or Post Anesthetic Care Unit. Vital signs and recovery times are recorded as part of standard care.
Approximately 1 post-operative visit (in-person)
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
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