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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
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 10
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Turkey
Marmara University Pendik Research and Training Hospital
RECRUITING
Istanbul
Marmara University Pendik Research and Training Hospital
RECRUITING
Istanbul
Contact Information
Primary
Rukiye Seyma Eslek
seyma.eslek@gmail.com
+90 539 573 5400
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 150
Treatments
Experimental: Paedfusor Group
Anesthesia will be maintained using propofol with target-controlled infusion based on the Paedfusor pharmacokinetic model.
Experimental: Eleveld Group
Anesthesia will be maintained using propofol with target-controlled infusion based on the Eleveld pharmacokinetic model.
Active_comparator: Sevoflurane Group
Anesthesia will be maintained using sevoflurane inhalational anesthesia.
Related Therapeutic Areas
Sponsors
Leads: Marmara University Pendik Training and Research Hospital

This content was sourced from clinicaltrials.gov