Emergence Delirium in Pediatric Anesthesia, Pediatric Anesthesia, Postoperative Agitations in Pediatric Patients, Postoperative Nausea and Vomiting (PONV)
Conditions
Keywords
pediatric anesthesia, paedfusor, eleveld, target controlled infusion, sevoflurane, postoperative agitation
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
Interventions
DRUGpropofol ( Paedfusor Model)
Propofol will be administered via target-controlled infusion using a Paedfusor model.
DRUGpropofol (Eleveld Model)
Propofol will be administered via target-controlled infusion using the Eleveld model.
DRUGSevofluorane
Sevoflurane will be administered as an inhalation anesthetic.
Sponsors
Marmara University Pendik Training and Research Hospital
Study design
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Delirium Assessed by PAED Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Assessed by FLACC Scale | Within the first 120 minutes after surgery | Postoperative pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. |
| Association Between BIS-Derived Alpha Band Power and Emergence Delirium | Intraoperative period | The relationship between bispectral index (BIS)-derived alpha frequency band power and emergence delirium will be evaluated in patients who develop emergence delirium. |
| Time to Emergence | Within the first 120 minutes after surgery | Time from discontinuation of anesthesia to eye opening and response to verbal stimuli. |
| Incidence of Postoperative Nausea and Vomiting | Within 30 minutes after the surgery | Occurrence of nausea and/or vomiting in the postoperative period. |
| Duration of BIS Suppression | Intraoperative period | Total duration of electroencephalographic suppression periods as detected by BIS monitoring during anesthesia. |
| Need for Additional Sedation | 0-30 minutes postoperatively | Requirement for rescue sedative medication in the postoperative period. |
| Need for Additional Analgesia | 0-30 minutes postoperatively | Requirement for rescue analgesic medication in the postoperative period. |
Countries
Turkey (Türkiye)
Contacts
CONTACTRukiye Seyma Eslek
Outcome results
None listed