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New treatment option for Emergence Delirium in Pediatric Anesthesia
Official title The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients
ClinicalTrials.gov ID: NCT07534956
What this study is testing
What is propofol ( Paedfusor Model)?
propofol ( Paedfusor Model) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for emergence delirium in pediatric anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 10. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 10 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.