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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Anesthesia; Postoperative Agitations in Pediatric Patients; Postoperative Nausea and Vomiting (PONV); Emergence Delirium in Pediatric Anesthesia
• Intervention / Treatment: Drug: propofol ( Paedfusor Model); Drug: propofol (Eleveld Model); Drug: Sevofluorane

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rukiye Seyma Eslek; Phone Number: +90 539 573 5400; Email: seyma.eslek@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34890
    • Recruiting
    • Marmara University Pendik Research and Training Hospital
    • Contact: Rukiye Seyma Eslek, MD (Resident); Phone Number: +90 539 573 5400; Email: seyma.eslek@gmail.com
    • Principal Investigator: Nazan Atalan Özlen
    • Sub-Investigator: Rukiye Seyma Eslek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paedfusor Group; Anesthesia will be maintained using propofol with target-controlled infusion based on the Paedfusor pharmacokinetic model.	Drug: propofol ( Paedfusor Model); Propofol will be administered via target-controlled infusion using a Paedfusor model.
Experimental: Eleveld Group; Anesthesia will be maintained using propofol with target-controlled infusion based on the Eleveld pharmacokinetic model.	Drug: propofol (Eleveld Model); Propofol will be administered via target-controlled infusion using the Eleveld model.
Active Comparator: Sevoflurane Group; Anesthesia will be maintained using sevoflurane inhalational anesthesia.	Drug: Sevofluorane; Sevoflurane will be administered as an inhalation anesthetic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence Delirium Assessed by PAED Scale	Postoperative awakening delirium and its severity will be assessed using the Pediatric Anesthesia Awakening Delirium (PAED) scale.	Within the first 30 minutes after emergence from anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Assessed by FLACC Scale	Postoperative pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.	Within the first 120 minutes after surgery
Association Between BIS-Derived Alpha Band Power and Emergence Delirium	The relationship between bispectral index (BIS)-derived alpha frequency band power and emergence delirium will be evaluated in patients who develop emergence delirium.	Intraoperative period
Time to Emergence	Time from discontinuation of anesthesia to eye opening and response to verbal stimuli.	Within the first 120 minutes after surgery
Incidence of Postoperative Nausea and Vomiting	Occurrence of nausea and/or vomiting in the postoperative period.	Within 30 minutes after the surgery
Duration of BIS Suppression	Total duration of electroencephalographic suppression periods as detected by BIS monitoring during anesthesia.	Intraoperative period
Need for Additional Sedation	Requirement for rescue sedative medication in the postoperative period.	0-30 minutes postoperatively
Need for Additional Analgesia	Requirement for rescue analgesic medication in the postoperative period.	0-30 minutes postoperatively

Collaborators and Investigators

• Sponsor: Marmara University Pendik Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sevoflurane; pediatric anesthesia; postoperative agitation; target controlled infusion; paedfusor; eleveld
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol
• Other Study ID Numbers: 96-01-16-ANES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and ethical considerations, including the protection of personal health information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No