Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
Healthy Volunteers
NCT07534956

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

Led by Marmara University Pendik Training and Research Hospital · Updated on 2026-04-16

150

Participants Needed

2

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 10 years
  • Children weighing over 10 kg
  • American Society of Anesthesiologists (ASA) physical status classification I-II
  • Scheduled for planned urogenital surgery under general anesthesia
  • Written informed consent obtained from parents or legal guardians
Not Eligible

You will not qualify if you...

  • Patients with ASA classification III or higher
  • Known neurological or psychiatric disorders
  • Developmental delay or cognitive impairment
  • Use of sedatives or psychoactive drugs
  • Allergy or contraindication to propofol or sevoflurane
  • History of previous adverse reactions to anesthesia
  • Patients requiring emergency surgery
  • Significant liver, kidney, or cardiovascular disease
  • Parents or legal guardians have not given consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye), 34890

Actively Recruiting

2

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye), 34890

Actively Recruiting

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Research Team

R

Rukiye Seyma Eslek

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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