Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia
NCT ID: NCT05725382
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
264 participants
INTERVENTIONAL
2023-06-01
2025-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators hypothesize that pain monitor-guided administration of remifentanil can reduce pain postoperatively compared with standard care.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Nociception Guided by NoL Index and PK of Fentanyl in Pediatric Patients Under General Anesthesia
NCT04786275
Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia
NCT00949507
Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia
NCT02683837
Residual Neuromuscular Blockade in Pediatric Anesthesia
NCT02939911
Optimum Dose of Remifentanil for Intubation in Small Children
NCT00474071
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In the present study the investigators aim to investigate whether administration of perioperative remifentanil guided by the CE-certified Pain Monitoring Device monitor-PMD200™, also called NOL-monitor, can reduce pain (primary endpoint), opioid consumption and agitation in children aged 3-16 years undergoing surgery with intravenous anesthesia.
The investigators hypothesize that NOL-guided perioperative remifentanil administration can reduce postoperative pain compared with standard clinical care (remifentanil dosing based on hemodynamic variables).
All patients will receive standard analgesia and antiemetic administered perioperatively:
* IV paracetamol 15 mg/kg
* IV Ibuprofen 10 mg/kg, unless contraindicated
* IV Morphine 25-100 μg/kg according to the extent of surgery and the departments' standard, administered 30 minutes before end of surgery (will not be included in the total perioperative or postoperative opioid consumption)
* In case of minor surgery, 1-2 μg/kg fentanyl, according to the department's standard, may be administered instead of morphine at the discretion of the anesthetist (will not be included in the total perioperative or postoperative opioid consumption)
* Regional anesthesia may be provided at the discretion of the anesthetist
* IV ondansetron 100 μg/kg
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NOL-guided remifentanil dosing
Remifentanil dosing will preferentially be guided by the NOL index, but blood pressure and heart rate will be monitored and considered concurrently.
* If the NOL index is \> 25, remifentanil infusion will be increased.
* If the NOL index is \< 10 the remifentanil infusion rate will be reduced
The NOL monitor (Pain Monitoring Device monitor-PMD200™)
NOL-guided perioperative remifentanil administration
Standard care remifentanil dosing
Remifentanil dosing will be administered according to standard care per institutional practice.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The NOL monitor (Pain Monitoring Device monitor-PMD200™)
NOL-guided perioperative remifentanil administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled surgery requiring intraoperative opioid administration
* Planned maintenance anesthesia with propofol and remifentanil
* The trial subject's custody holders' must be able to understand the trial protocol, risks, and benefits, and provide signed informed consent
Exclusion Criteria
* Children who cannot cooperate to the study assessments based on the investigators' evaluation. This may be children with mental disorders, visual disturbances, hearing or speech impairment etc. interfering with assessments.
* Arrythmias, either known arrythmias preoperatively or arrythmias detected within the first minutes perioperatively (in which case the patient will be excluded post- randomization).
* Allergy to the medicines used in the study
* Daily intake of opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
* Weight \< 10 kg
3 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pia Jaeger, MD, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pia Jaeger, MD, PhD
Senior Registrar
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pia Jæger, MD, PhD
Role: STUDY_CHAIR
Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet
Copenhagen, , Denmark
Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Department of Anaesthesia, Sjællands Universitetshospital, Køge
Køge, , Denmark
Department of Anaesthesia, Vejle Sygehus
Vejle, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NOL1-2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.