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

NCT07534956 | Recruiting

• 1 other identifier: 96-01-16-ANES
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

pediatric anesthesia; paedfusor; eleveld; target controlled infusion; sevoflurane; postoperative agitation

Outcome Measures

Primary Outcomes (1)

• Emergence Delirium Assessed by PAED Scale

  Postoperative awakening delirium and its severity will be assessed using the Pediatric Anesthesia Awakening Delirium (PAED) scale.

  Within the first 30 minutes after emergence from anesthesia

Secondary Outcomes (7)

• Postoperative Pain Assessed by FLACC Scale

  Within the first 120 minutes after surgery

• Association Between BIS-Derived Alpha Band Power and Emergence Delirium

  Intraoperative period

• Time to Emergence

  Within the first 120 minutes after surgery

• Incidence of Postoperative Nausea and Vomiting

  Within 30 minutes after the surgery

• Duration of BIS Suppression

  Intraoperative period

Study Arms (3)

Paedfusor Group

EXPERIMENTAL

Anesthesia will be maintained using propofol with target-controlled infusion based on the Paedfusor pharmacokinetic model.

Drug: propofol ( Paedfusor Model)

Eleveld Group

EXPERIMENTAL

Anesthesia will be maintained using propofol with target-controlled infusion based on the Eleveld pharmacokinetic model.

Drug: propofol (Eleveld Model)

Sevoflurane Group

ACTIVE COMPARATOR

Anesthesia will be maintained using sevoflurane inhalational anesthesia.

Drug: Sevofluorane

Interventions

Sevofluorane DRUG

Sevoflurane will be administered as an inhalation anesthetic.

Sevoflurane Group

propofol ( Paedfusor Model) DRUG

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

Paedfusor Group

propofol (Eleveld Model) DRUG

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

Eleveld Group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 may not qualify 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
• Patients requiring emergency surgery
• Significant liver, kidney, or cardiovascular disease
• Patients whose parents or legal guardians have not given consent

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (2)

Marmara University Pendik Research and Training Hospital

Istanbul, 34890, Turkey (Türkiye)

RECRUITING

Marmara University Pendik Research and Training Hospital

Istanbul, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Propofol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Rukiye Seyma Eslek

CONTACT

+90 539 573 5400; seyma.eslek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because the application methods of anesthesia techniques differ, blinding the anesthesiologist is not possible. However, the primary endpoint of the study, postoperative awakening agitation, will be assessed in the postoperative recovery unit using the PAED (Pediatric Anesthesia Emergency Delirium) scale by a blinded evaluator unaware of the group assignment. The personnel performing the PAED assessment will not have access to the randomization list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist prof

Model Details: Participants aged 3-10 years with ASA physical status I-II undergoing elective urogenital surgery will be assigned to three parallel groups in a 1:1:1 ratio: Paedfusor TCI model, Eleveld TCI model, or sevoflurane anesthesia. Randomification will be performed using computer-based variable block randomization to maintain sample balance between groups, with block sizes of 6 and 9. The randomization list will be generated by an independent investigator not involved in patient recruitment or anesthesia administration. The aim of the study is to compare the effects of these anesthesia techniques on postoperative awakening delirium and agitation. Standard monitoring and anesthesia protocols will be applied to all groups. Postoperative awakening delirium and agitation will be assessed using clinically validated scales.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 16, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)