The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awak
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 (Paedfuso
| Condition(s) | Emergence Delirium in Pediatric Anesthesia, Pediatric Anesthesia, Postoperative Agitations in Pediatric Patients, Postoperative Nausea and Vomiting (PONV) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 g |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Marmara University Pendik Training and Research Hospital |
| Locations | Istanbul, Turkey (Türkiye); Istanbul, Turkey (Türkiye) |
| Start date | 2026-01-13 |
| NCT ID | NCT07534956 |
| Official listing | https://clinicaltrials.gov/study/NCT07534956 |