Actively Recruiting
The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients
Led by Marmara University Pendik Training and Research Hospital · Updated on 2026-04-16
150
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Emergence delirium is a common complication in pediatric patients undergoing general anesthesia. The aim of this study is to investigate the incidence of postoperative awakening delirium and agitation in pediatric patients aged 3-10 years (ASA I-II) using two different target-controlled infusion (TCI) methods (Paedfusor and Eleveld) for TIVA, compared to inhalation anesthesia. This study will examine the effect of two different TCI models on postoperative awakening agitation/delirium by comparing them with each other and with inhalation anesthesia.
CONDITIONS
Official Title
The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 10 years
- Children weighing over 10 kg
- American Society of Anesthesiologists (ASA) physical status classification I-II
- Scheduled for planned urogenital surgery under general anesthesia
- Written informed consent obtained from parents or legal guardians
You will not qualify if you...
- Patients with ASA classification III or higher
- Known neurological or psychiatric disorders
- Developmental delay or cognitive impairment
- Use of sedatives or psychoactive drugs
- Allergy or contraindication to propofol or sevoflurane
- History of previous adverse reactions to anesthesia
- Patients requiring emergency surgery
- Significant liver, kidney, or cardiovascular disease
- Parents or legal guardians have not given consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Marmara University Pendik Research and Training Hospital
Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
2
Marmara University Pendik Research and Training Hospital
Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
Research Team
R
Rukiye Seyma Eslek
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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