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

NCT07534956 · tracked via the Priya Life Science Turkey tracker

Sponsor

Marmara University Pendik Training and Research Hospital

Phase

Not applicable

Started

2026-01-13

Last updated

2026-04-16

Condition(s) studied

Emergence Delirium in Pediatric AnesthesiaPediatric AnesthesiaPostoperative Agitations in Pediatric PatientsPostoperative Nausea and Vomiting (PONV)

Investigational drug(s) / intervention(s)

propofol ( Paedfusor Model) →propofol (Eleveld Model) →Sevofluorane

propofol ( Paedfusor Model): Propofol will be administered via target-controlled infusion using a Paedfusor model.

propofol (Eleveld Model): Propofol will be administered via target-controlled infusion using the Eleveld model.

Sevofluorane: Sevoflurane will be administered as an inhalation anesthetic.

Study 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.

Eligibility

Sex

ALL

Min age

3 Years

Max age

10 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
Marmara University Pendik Research and Training Hospital	Istanbul	Turkey (Türkiye)	Recruiting
Marmara University Pendik Research and Training Hospital	Istanbul	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07534956 on ClinicalTrials.gov ↗ ← All trials in Turkey