Comparing Paedfusor and Eleveld propofol TCI versus sevoflurane for reducing wake-up agitation in children
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | Marmara University Pendik Training and Research Hospital Academic / other |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT07534956 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.