The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients
Recruiting now · Not applicable
Conditions studied: Emergence Delirium in Pediatric Anesthesia, Pediatric Anesthesia, Postoperative Agitations in Pediatric Patients, Postoperative Nausea and Vomiting (PONV)
In brief
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.
Key facts
- Study ID
- NCT07534956
- Run by
- Marmara University Pendik Training and Research Hospital
- People needed
- 150
- Starts
- 2026-01-13
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2026-04-16
Who can join
Age: 3 and older, up to 10. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Marmara University Pendik Research and Training Hospital — Istanbul, Turkey (Türkiye) (enrolling)
- Marmara University Pendik Research and Training Hospital — Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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