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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Marmara University Pendik Training and Research Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Emergence Delirium Assessed by PAED Scale
Overview
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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 3 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Paedfusor Group
Anesthesia will be maintained using propofol with target-controlled infusion based on the Paedfusor pharmacokinetic model.
Intervention: propofol ( Paedfusor Model) (Drug)
Eleveld Group
Anesthesia will be maintained using propofol with target-controlled infusion based on the Eleveld pharmacokinetic model.
Intervention: propofol (Eleveld Model) (Drug)
Sevoflurane Group
Anesthesia will be maintained using sevoflurane inhalational anesthesia.
Intervention: Sevofluorane (Drug)
Outcomes
Primary Outcomes
Emergence Delirium Assessed by PAED Scale
Time Frame: Within the first 30 minutes after emergence from anesthesia
Postoperative awakening delirium and its severity will be assessed using the Pediatric Anesthesia Awakening Delirium (PAED) scale.
Secondary Outcomes
- 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)
- Need for Additional Sedation(0-30 minutes postoperatively)
- Need for Additional Analgesia(0-30 minutes postoperatively)
Investigators
dilara gocmen
Assist prof
Marmara University Pendik Training and Research Hospital