NCT07534956

The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Marmara University Pendik Training and Research Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Accepted

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.

Detailed description

Postoperative emergence agitation/delirium (POED) is a postoperative complication in pediatric anesthesia and is characterized by perceptual and psychomotor impairment that negatively impacts postoperative recovery. According to the literature, inhalation anesthesia is associated with a higher incidence of ED compared to propofol-based anesthesia. In this study, we aimed to investigate the effect of two different TCI models, in which the depth of general anesthesia was monitored with BIS monitoring, on reducing the incidence of ED. Both the Paedfusor and Eleveld models describe propofol pharmacokinetics via a three-compartment structure. These pharmacokinetic models are drug infusion models created by taking 600-10,000 blood samples at specific intervals after administering various doses of the drug to real patients and measuring the blood concentrations. They are used to provide a more stable and consistent level of total intravenous anesthesia. Both models have been used for propofol infusion in pediatric anesthesia for many years. Differences exist between them in terms of distribution volume, elimination rate constant between compartments, and induction and maintenance phases depending on the characteristics of the pharmacokinetic model used. These models are already loaded onto perfusion devices in the operating room. Patient data such as height, weight, and gender are entered into the device, the target dose is determined by the clinician, and the device calculates the necessary dose for induction and maintenance according to the pharmacokinetic models. This study was designed as a prospective, randomized, controlled, single-blind (evaluator-blind), three-arm clinical trial comparing the effects of total intravenous anesthesia and inhalation anesthesia, administered with two different target-controlled infusion (TCI) models (Paedfusor and Eleveld), on postoperative awakening agitation in pediatric patients aged 3-10 years with ASA I-II status and scheduled for elective urogenital surgery. Participants will be randomly assigned to one of three groups: Paedfusor TCI, Eleveld TCI, or sevoflurane anesthesia. Standard monitoring and anesthesia protocols will be applied to all patients. Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale, and postoperative pain will be evaluated using the FLACC scale. Secondary outcomes include severity of emergence delirium, association between bispectral index (BIS)-derived alpha band power and ED, time to emergence, postoperative nausea and vomiting, duration of BIS suppression, and the need for additional sedation and analgesia. This study aims to provide evidence on the optimal anesthetic approach to reduce emergence delirium in pediatric patients and to explore the neurophysiological correlates of ED using BIS monitoring

Conditions

• Emergence Delirium in Pediatric Anesthesia
• Pediatric Anesthesia
• Postoperative Agitations in Pediatric Patients
• Postoperative Nausea and Vomiting (PONV)

Interventions

Type	Name	Description
DRUG	propofol ( Paedfusor Model)	Propofol will be administered via target-controlled infusion using a Paedfusor model.
DRUG	propofol (Eleveld Model)	Propofol will be administered via target-controlled infusion using the Eleveld model.
DRUG	Sevofluorane	Sevoflurane will be administered as an inhalation anesthetic.

Timeline

• Start date: 2026-01-13
• Primary completion: 2027-10-01
• Completion: 2027-11-30
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

2 sites across 1 country: Turkey (Türkiye)