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

Marmara University Pendik Training and Research Hospital

Status: Enrolling

Conditions: Postoperative Nausea and Vomiting (PONV); Emergence Delirium in Pediatric Anesthesia; Postoperative Agitations in Pediatric Patients; Pediatric Anesthesia

Treatments: Drug: Sevofluorane; Drug: propofol ( Paedfusor Model); Drug: propofol (Eleveld Model)

Study type: Interventional

Funder types: Other

Identifiers

NCT07534956

96-01-16-ANES

Details and patient eligibility

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.

Full description

Postoperative emergence agitation/delirium (POED) is a postoperative complication in pediatric anesthesia and is characterized by perceptual and psychomotor impairment that negatively impacts postoperative recovery. According to the literature, inhalation anesthesia is associated with a higher incidence of ED compared to propofol-based anesthesia. In this study, we aimed to investigate the effect of two different TCI models, in which the depth of general anesthesia was monitored with BIS monitoring, on reducing the incidence of ED.

Both the Paedfusor and Eleveld models describe propofol pharmacokinetics via a three-compartment structure. These pharmacokinetic models are drug infusion models created by taking 600-10,000 blood samples at specific intervals after administering various doses of the drug to real patients and measuring the blood concentrations. They are used to provide a more stable and consistent level of total intravenous anesthesia.

Both models have been used for propofol infusion in pediatric anesthesia for many years. Differences exist between them in terms of distribution volume, elimination rate constant between compartments, and induction and maintenance phases depending on the characteristics of the pharmacokinetic model used. These models are already loaded onto perfusion devices in the operating room. Patient data such as height, weight, and gender are entered into the device, the target dose is determined by the clinician, and the device calculates the necessary dose for induction and maintenance according to the pharmacokinetic models.

This study was designed as a prospective, randomized, controlled, single-blind (evaluator-blind), three-arm clinical trial comparing the effects of total intravenous anesthesia and inhalation anesthesia, administered with two different target-controlled infusion (TCI) models (Paedfusor and Eleveld), on postoperative awakening agitation in pediatric patients aged 3-10 years with ASA I-II status and scheduled for elective urogenital surgery.

Participants will be randomly assigned to one of three groups: Paedfusor TCI, Eleveld TCI, or sevoflurane anesthesia. Standard monitoring and anesthesia protocols will be applied to all patients. Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale, and postoperative pain will be evaluated using the FLACC scale.

Secondary outcomes include severity of emergence delirium, association between bispectral index (BIS)-derived alpha band power and ED, time to emergence, postoperative nausea and vomiting, duration of BIS suppression, and the need for additional sedation and analgesia.

This study aims to provide evidence on the optimal anesthetic approach to reduce emergence delirium in pediatric patients and to explore the neurophysiological correlates of ED using BIS monitoring

Enrollment: 150 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Paedfusor Group

Experimental group

Description:

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

Treatment:

Drug: propofol ( Paedfusor Model)

Eleveld Group

Experimental group

Description:

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

Treatment:

Drug: propofol (Eleveld Model)

Sevoflurane Group

Active Comparator group

Description:

Anesthesia will be maintained using sevoflurane inhalational anesthesia.

Treatment:

Drug: Sevofluorane