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

NCT07534956 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-16

No results posted yet for this 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.

Conditions

  • Emergence Delirium in Pediatric Anesthesia
  • Pediatric Anesthesia
  • Postoperative Agitations in Pediatric Patients
  • Postoperative Nausea and Vomiting (PONV)

Interventions

DRUG

propofol ( Paedfusor Model)

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

DRUG

propofol (Eleveld Model)

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

DRUG

Sevofluorane

Sevoflurane will be administered as an inhalation anesthetic.

Sponsors & Collaborators

  • Marmara University Pendik Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2027-10-01
Completion
2027-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534956 on ClinicalTrials.gov