Emergence Delirium in Pediatric AnesthesiaNCT07534956
The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients
A study testing propofol ( Paedfusor Model), propofol (Eleveld Model) and Sevofluorane in people with Emergence Delirium in Pediatric Anesthesia and Pediatric Anesthesia, run by Marmara University Pendik Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium in Pediatric Anesthesia, Pediatric Anesthesia, Postoperative Agitations in Pediatric Patients
- What is being tested?
- propofol ( Paedfusor Model), propofol (Eleveld Model) and Sevofluorane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 Jan 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients requiring emergency surgery
- Significant liver, kidney, or cardiovascular disease
- Patients whose parents or legal guardians have not given consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Marmara University Pendik Research and Training Hospital
Istanbul, 34890
Rukiye Seyma Eslek, MD, +90 539 5735400, seyma.eslek@gmail.com
- Recruiting
Marmara University Pendik Research and Training Hospital
Istanbul, 34890
Rukiye Seyma Eslek, MD (Resident), +90 539 573 5400, seyma.eslek@gmail.com
Nazan Atalan Özlen
About this study
Official title: 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
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.
Read the 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
- Conditions
- Emergence Delirium in Pediatric Anesthesia, Pediatric Anesthesia, Postoperative Agitations in Pediatric Patients, Postoperative Nausea and Vomiting (PONV)
- Being tested
- propofol ( Paedfusor Model), propofol (Eleveld Model), Sevofluorane
- Keywords
- pediatric anesthesia, paedfusor, eleveld, target controlled infusion, sevoflurane, postoperative agitation
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol ( Paedfusor Model)Drug
Propofol will be administered via target-controlled infusion using a Paedfusor model.
propofol (Eleveld Model)Drug
Propofol will be administered via target-controlled infusion using the Eleveld model.
SevofluoraneDrug
Sevoflurane will be administered as an inhalation anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Paedfusor Group | Experimental | Anesthesia will be maintained using propofol with target-controlled infusion based on the Paedfusor pharmacokinetic model. Receives: Drug: propofol ( Paedfusor Model) |
| Eleveld Group | Experimental | Anesthesia will be maintained using propofol with target-controlled infusion based on the Eleveld pharmacokinetic model. Receives: Drug: propofol (Eleveld Model) |
| Sevoflurane Group | Active comparator | Anesthesia will be maintained using sevoflurane inhalational anesthesia. Receives: Drug: Sevofluorane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence Delirium Assessed by PAED Scale
Postoperative awakening delirium and its severity will be assessed using the Pediatric Anesthesia Awakening Delirium (PAED) scale.
Measured: Within the first 30 minutes after emergence from anesthesia
Secondary outcomes (7)
Postoperative Pain Assessed by FLACC Scale
Postoperative pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.
Measured: Within the first 120 minutes after surgery
Association Between BIS-Derived Alpha Band Power and Emergence Delirium
The relationship between bispectral index (BIS)-derived alpha frequency band power and emergence delirium will be evaluated in patients who develop emergence delirium.
Measured: Intraoperative period
Time to Emergence
Time from discontinuation of anesthesia to eye opening and response to verbal stimuli.
Measured: Within the first 120 minutes after surgery
Incidence of Postoperative Nausea and Vomiting
Occurrence of nausea and/or vomiting in the postoperative period.
Measured: Within 30 minutes after the surgery
Duration of BIS Suppression
Total duration of electroencephalographic suppression periods as detected by BIS monitoring during anesthesia.
Measured: Intraoperative period
Need for Additional Sedation
Requirement for rescue sedative medication in the postoperative period.
Measured: 0-30 minutes postoperatively
Need for Additional Analgesia
Requirement for rescue analgesic medication in the postoperative period.
Measured: 0-30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Jan 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium in Pediatric AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilara gocmen, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534956
- Sponsor's protocol ID
- 96-01-16-ANES
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical considerations, including the protection of personal health information.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07534956
- Acronym / sponsor ID
- 96-01-16-ANES
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paedfusor Group | Experimental | Drug: propofol ( Paedfusor Model)Anesthesia will be maintained using propofol with target-controlled infusion based on the Paedfusor pharmacokinetic model. |
| Eleveld Group | Experimental | Drug: propofol (Eleveld Model)Anesthesia will be maintained using propofol with target-controlled infusion based on the Eleveld pharmacokinetic model. |
| Sevoflurane Group | Active comparator | Drug: SevofluoraneAnesthesia will be maintained using sevoflurane inhalational anesthesia. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol ( Paedfusor Model)Propofol will be administered via target-controlled infusion using a Paedfusor model. | Drug | Paedfusor Group |
| propofol (Eleveld Model)Propofol will be administered via target-controlled infusion using the Eleveld model. | Drug | Eleveld Group |
| SevofluoraneSevoflurane will be administered as an inhalation anesthetic. | Drug | Sevoflurane Group |
Primary outcome
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.
7 secondary outcomes
Postoperative Pain Assessed by FLACC Scale
Time frame: Within the first 120 minutes after surgery
Association Between BIS-Derived Alpha Band Power and Emergence Delirium
Time frame: Intraoperative period
Time to Emergence
Time frame: Within the first 120 minutes after surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: Within 30 minutes after the surgery
Duration of BIS Suppression
Time frame: Intraoperative period
Need for Additional Sedation
Time frame: 0-30 minutes postoperatively
Need for Additional Analgesia
Time frame: 0-30 minutes postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical considerations, including the protection of personal health information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol ( Paedfusor Model), propofol (Eleveld Model) and Sevofluorane in people with Emergence Delirium in Pediatric Anesthesia and Pediatric Anesthesia, run by Marmara University Pendik Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rukiye Seyma Eslek (+90 539 573 5400, seyma.eslek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence Delirium Assessed by PAED Scale (time frame: Within the first 30 minutes after emergence from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.