RecruitingNot ApplicableNCT07534956

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


Sponsor

Marmara University Pendik Training and Research Hospital

Enrollment

150 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 10 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGpropofol ( Paedfusor Model)

Propofol will be administered via target-controlled infusion using a Paedfusor model.

DRUGpropofol (Eleveld Model)

Propofol will be administered via target-controlled infusion using the Eleveld model.

DRUGSevofluorane

Sevoflurane will be administered as an inhalation anesthetic.


Locations(2)

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07534956


Related Trials