Comparing Paedfusor and Eleveld propofol TCI versus sevoflurane for reducing wake-up agitation in children
Official title: Investigation of the Effects of Two Different TCI (Target Controlled Infusion) Models (Paedfusor and Eleveld) and Inhalation Anesthesia on Postoperative Awakening Agitation/Delirium in Pediatric Patients
Run by Marmara University Pendik Training and Research Hospital · NCT07534956 · Data updated 2026-11-12
This project will test whether two propofol target-controlled infusion methods (Paedfusor and Eleveld) or sevoflurane inhalation better prevent awakening agitation in children aged 3–10 having planned urogenital surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 10 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Marmara University Pendik Training and Research Hospital Academic / other |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07534956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–10 years who weigh more than 10 kg, are ASA I–II, scheduled for planned urogenital surgery, and whose parents provide written consent.
✕Probably not a fit
Children with ASA III or higher, known neurological or psychiatric disorders, developmental delay, current use of sedatives or psychoactive drugs, allergies to propofol or sevoflurane, emergency surgery, or significant liver/kidney/cardiovascular disease are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two propofol target-controlled infusion (TCI) models—Paedfusor and Eleveld—against sevoflurane inhalation in children aged 3–10 years (ASA I–II) undergoing planned urogenital surgery. Anesthesia depth will be monitored with BIS while propofol is delivered using pumps programmed with the respective pharmacokinetic models. The primary outcome is the incidence of emergence delirium/awakening agitation, with secondary outcomes including postoperative nausea and vomiting. The trial compares the incidence of postoperative agitation between the two TCI methods and inhalational anesthesia to see if one approach yields smoother recovery.
Why it matters
Potential benefit: If successful, this could reduce emergence delirium and improve comfort and safety during recovery for young children after anesthesia.
How similar studies have gone: Prior studies indicate propofol-based anesthesia is associated with lower rates of emergence delirium than inhalational agents, and both Paedfusor and Eleveld TCI models have been used in pediatric anesthesia, though direct comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 3-10 years * Children weighing over 10 kg * American Society of Anesthesiologists (ASA) physical condition classification I-II * Those who will undergo planned urogenital surgery under general anesthesia * Those who have obtained written informed consent from their parents or legal guardians Exclusion Criteria: * Patients assessed as ASA III or higher * Known neurological or psychiatric disorders * Developmental delay or cognitive impairment * Use of sedatives or psychoactive drugs * Allergy or contraindication to the study drugs (propofol or sevoflurane) * History of previous adverse reactions to anesthesia * Patients requiring emergency surgery * Significant liver, kidney, or cardiovascular disease * Patients whose parents or legal guardians have not given consent
Where it's running
-
Marmara University Pendik Research and Training Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Marmara University Pendik Research and Training Hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Rukiye Seyma Eslek
- Email: seyma.eslek@gmail.com
- Phone: +90 539 573 5400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.