Emergence Delirium (Derlenme Deliryumu)NCT07826559
Brain Monitors to Reduce Child Confusion After Anesthesia
A study testing BIS-Guided Anesthesia in people with Emergence Delirium (Derlenme Deliryumu), run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to learn if using a brain monitor to adjust anesthesia (sleep medicine) during surgery could prevent emergence delirium (severe confusion and agitation upon waking) in children aged 2 to 12 years having their tonsils or adenoids removed. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium (Derlenme Deliryumu)
- What is being tested?
- BIS-Guided Anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2025to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 2 and 12 years
- Scheduled for a planned surgery to remove adenoids, tonsils, or both
- Generally healthy or having only mild medical conditions (American Society of Anesthesiologists class I or II)
- Expected to have a surgery that lasts less than 4 hours
- Having the procedure as an outpatient and expected to go home the same day
Who cannot join
- Having severe medical conditions (American Society of Anesthesiologists class III or IV)
- Having a known history of neurological or psychiatric diseases
- Diagnosed with a developmental delay
- Having severe heart, lung, or metabolic conditions
- Having a known allergy to any of the medications used in the study
- Parents or legal guardians refuse to provide written consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of BIS-Guided Anesthesia in Reducing Emergence Delirium in Children (Çocuklarda Derlenme Deliryumunun Azaltılmasında BİS Kılavuzluğunda Anestezi)
The goal of this clinical trial was to learn if using a brain monitor to adjust anesthesia (sleep medicine) during surgery could prevent emergence delirium (severe confusion and agitation upon waking) in children aged 2 to 12 years having their tonsils or adenoids removed. The main questions it aimed to answer were:
Did using a brain monitor lower the chance of children waking up confused and upset?
Read more
Did using the brain monitor reduce the amount of anesthesia gas (sevoflurane) needed during surgery, and did it affect recovery time or pain levels?
Researchers compared anesthesia adjusted using a bispectral index (BIS) brain monitor to anesthesia adjusted using standard care to see if the brain monitor lowered the chance of emergence delirium.
Participants in the study:
Received general anesthesia (a standardized mix of inhaled and intravenous medicines, including sevoflurane and fentanyl) to safely sleep through surgery to remove their tonsils or adenoids
Had the dose of their main anesthesia gas (sevoflurane) adjusted during surgery based on either brain monitor readings (targeting a specific sleep depth of 40-60) or standard physical responses (like heart rate and blood pressure)
Were checked by the research team immediately after waking up to measure their confusion, agitation, and pain using standard clinical rating scales
Read the detailed description
Emergence delirium (ED) represents a significant neurobehavioral complication that frequently occurs during the immediate postoperative period in pediatric populations, particularly following otorhinolaryngological procedures such as adenoidectomy and tonsillectomy. Characterized by severe agitation, altered awareness, disturbed psychomotor behavior, and inconsolability, ED poses safety risks to the recovering patient and increases the burden on healthcare providers and caregivers. While the etiology of ED is multifactorial, the intraoperative depth of anesthesia and the cumulative exposure to specific volatile anesthetics, such as sevoflurane, are known modifiable risk factors. Both excessively deep and inadequately light anesthesia can contribute to poor recovery profiles. The Bispectral Index (BIS) is an electroencephalogram (EEG)-based monitor that provides an objective measurement of a patient's level of consciousness, allowing anesthesiologists to precisely titrate anesthetic agents to an optimal depth.
This prospective, randomized controlled study was designed to investigate the role of BIS-guided anesthetic titration in mitigating the risk of ED. Upon enrollment, pediatric patients undergoing adenoidectomy and/or tonsillectomy were randomized into one of two clinical care pathways: a BIS-guided anesthesia group or a standard-care group.
To ensure baseline consistency across the study, all participants followed a standardized anesthetic induction protocol. Following routine premedication, general anesthesia was induced using inhaled sevoflurane combined with intravenous lidocaine, rocuronium (for muscle relaxation), and fentanyl (for analgesia). For the maintenance phase of anesthesia, patients in both arms received a combination of inhaled sevoflurane and continuous remifentanil infusions.
The critical divergence in the study protocol occurred during the intraoperative maintenance phase:
BIS-Guided Pathway: Anesthesiologists continuously monitored the patient's EEG activity using the BIS monitor. The concentration of the sevoflurane gas was deliberately titrated to maintain a BIS value between 40 and 60, which represents an optimal and safe depth for surgical anesthesia. By keeping patients within this precise target range, the protocol systematically avoided periods of excessively deep (BIS < 40) or overly light (BIS > 60) anesthesia.
Standard-Care Pathway: Anesthesiologists adjusted the sevoflurane concentrations based entirely on traditional clinical signs and autonomic responses, specifically monitoring hemodynamic fluctuations such as heart rate and blood pressure, without the use of EEG-guided depth parameters.
Following the completion of the surgical procedure, patients were transferred to the post-anesthesia care unit (PACU) for close observation. The clinical team systematically evaluated the patients' transition from unconsciousness to wakefulness. To ensure a robust, multi-faceted assessment of neurobehavioral status, the clinical staff utilized three validated behavioral assessment tools: the Pediatric Anesthesia Emergence Delirium (PAED) scale, the Watcha scale, and the Cravero scale. Simultaneously, postoperative physical pain was managed and tracked using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral scale.
If a patient exhibited signs meeting predetermined thresholds for severe emergence delirium (specifically, a PAED score of 10 or higher, a Watcha score of 3 to 4, or a Cravero score of 4 or higher), the clinical protocol dictated the administration of intravenous fentanyl as a rescue pharmacological intervention to safely manage the agitation.
Through this methodology, the study sought to define the relationship between strict, brain-monitored anesthetic titration and postoperative behavior. It comprehensively evaluated how preventing fluctuations in anesthetic depth impacts overall volatile anesthetic consumption, the necessity for rescue opioids in the recovery room, and the overall quality and speed of pediatric recovery following airway surgery.
- Conditions
- Emergence Delirium (Derlenme Deliryumu)
- Being tested
- BIS-Guided Anesthesia, Standard Care Anesthesia
- Keywords
- emergence delirium, pediatric anesthesia, bispectral index, anesthetic depth, adenoidectomy, tonsillectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-Guided AnesthesiaDevice
Anesthetic depth was continuously guided by the Bispectral Index (BIS) monitor. A single-use BIS sensor was placed on the patient's forehead before anesthesia induction to record real-time EEG activity. The primary inhaled anesthetic (sevoflurane) was continuously titrated throughout the surgery to strictly maintain a BIS value within the target range of 40 to 60. If the BIS value dropped below 40, the sevoflurane concentration was decreased. If the BIS value exceeded 60, the continuous remifentanil infusion (0.02-0.1 mcg/kg/min) was increased first, followed by an increase in sevoflurane if necessary. Intervention
Standard Care AnesthesiaDrug
Anesthetic depth was guided solely by traditional clinical signs and autonomic responses. The primary inhaled anesthetic (sevoflurane) was initiated at a 1% end-tidal concentration and adjusted in 0.25% increments (range 0.50% to 1.5%) to maintain the patient's heart rate and blood pressure within ±25% of their baseline pre-anesthesia values. Remifentanil was also infused continuously (0.02-0.1 mcg/kg/min) and adjusted based on clinical requirements. A BIS sensor was attached to the patient to record data, but the monitor screen was completely blinded to the anesthesia care provider, ensuring titration relied exclusively on standard hemodynamic metrics.
| Study group | Role | What they receive |
|---|---|---|
| BIS-Guided Anesthesia | Experimental | This group received the specific intervention (the BIS monitor to guide anesthesia depth) that is the main focus of your research study. Receives: Device: BIS-Guided Anesthesia |
| Standard Care Anesthesia | Active comparator | This group received the standard, established method of care (titrating anesthesia based on heart rate and blood pressure). Receives: Drug: Standard Care Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale
Evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale ranges from a minimum of 0 to a maximum of 20. Higher scores mean a worse outcome (more severe delirium). Scores of 10 or higher were classified as a positive diagnosis for emergence delirium.
Measured: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Primary Outcome Measure 2: Incidence of Emergence Delirium Assessed by the Watcha Scale
Evaluated postoperatively using the Watcha behavioral scale. The scale ranges from a minimum of 1 to a maximum of 4. Higher scores mean a worse outcome (greater agitation and delirium). Scores of 3 to 4 were classified as a positive diagnosis for emergence delirium.
Measured: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Primary Outcome Measure 3: Incidence of Emergence Delirium Assessed by the Cravero Scale
Evaluated postoperatively using the Cravero behavioral scale. The scale ranges from a minimum of 1 to a maximum of 5. Higher scores mean a worse outcome (greater agitation). Scores of 4 or higher were classified as a positive diagnosis for emergence delirium.
Measured: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Secondary outcomes (4)
Total Sevoflurane Consumption
The total volume of sevoflurane anesthetic gas consumed during the surgical procedure was measured in milliliters (mL).
Measured: Intraoperative (From anesthesia induction until the completion of surgery).
Postoperative Pain Assessed by the FLACC Scale
Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral scale. The scale ranges from a minimum of 0 to a maximum of 10. Higher scores mean a worse outcome (more severe pain). Scores of 4 or higher indicated the presence of pain.
Measured: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Rescue Opioid Usage
Administration of intravenous rescue fentanyl (administered at a dose of 1-2 mcg/kg) as an intervention for severe emergence delirium or inadequate pain control.
Measured: Up to 60 minutes during the post-anesthesia recovery period.
Recovery Time
Time required to meet safe discharge criteria from the post-anesthesia care unit, determined by the Modified Aldrete Score. The scale ranges from 0 to 10; higher scores mean a better outcome. A score of 9 or higher indicates readiness for discharge.
Measured: Up to 4 hours (From transfer to the recovery unit until discharge criteria were successfully met).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start8 Aug 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium (Derlenme Deliryumu)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilized a parallel assignment model. A total of 125 pediatric patients (aged 2 to 12 years) undergoing adenoidectomy and/or tonsillectomy were randomized in a 1:1 ratio into two distinct, simultaneous arms: the intervention group (BIS-guided anesthesia) and the active comparator group (standard care). During the intraoperative phase, both groups received identical anesthetic agents (sevoflurane and remifentanil). The fundamental difference between the parallel arms was the titration strategy. In the BIS arm, sevoflurane was titrated continuously to maintain a strict Bispectral Index target of 40-60. In the standard-care arm, anesthesiologists adjusted the sevoflurane dosage based entirely on traditional clinical and hemodynamic responses, such as heart rate and blood pressure. Participants remained in their initially assigned arms for the entire duration of the surgery and the postoperative recovery observation period. No crossover design was utilized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826559
- Sponsor's protocol ID
- KA24/328
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of BIS-Guided Anesthesia in Reducing Emergence Delirium in Children (Çocuklarda Derlenme Deliryumunun Azaltılmasında BİS Kılavuzluğunda Anestezi)
- ClinicalTrials.gov ID
- NCT07826559
- Acronym / sponsor ID
- KA24/328
- Conditions
- Emergence Delirium (Derlenme Deliryumu)
- Keywords
- emergence delirium, pediatric anesthesia, bispectral index, anesthetic depth, adenoidectomy, tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 17 Sep 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.
The goal of this clinical trial was to learn if using a brain monitor to adjust anesthesia (sleep medicine) during surgery could prevent emergence delirium (severe confusion and agitation upon waking) in children aged 2 to 12 years having their tonsils or adenoids removed. The main questions it aimed to answer were:
Did using a brain monitor lower the chance of children waking up confused and upset?
Did using the brain monitor reduce the amount of anesthesia gas (sevoflurane) needed during surgery, and did it affect recovery time or pain levels?
Researchers compared anesthesia adjusted using a bispectral index (BIS) brain monitor to anesthesia adjusted using standard care to see if the brain monitor lowered the chance of emergence delirium.
Participants in the study:
Received general anesthesia (a standardized mix of inhaled and intravenous medicines, including sevoflurane and fentanyl) to safely sleep through surgery to remove their tonsils or adenoids
Had the dose of their main anesthesia gas (sevoflurane) adjusted during surgery based on either brain monitor readings (targeting a specific sleep depth of 40-60) or standard physical responses (like heart rate and blood pressure)
Were checked by the research team immediately after waking up to measure their confusion, agitation, and pain using standard clinical rating scales
Detailed description
Emergence delirium (ED) represents a significant neurobehavioral complication that frequently occurs during the immediate postoperative period in pediatric populations, particularly following otorhinolaryngological procedures such as adenoidectomy and tonsillectomy. Characterized by severe agitation, altered awareness, disturbed psychomotor behavior, and inconsolability, ED poses safety risks to the recovering patient and increases the burden on healthcare providers and caregivers. While the etiology of ED is multifactorial, the intraoperative depth of anesthesia and the cumulative exposure to specific volatile anesthetics, such as sevoflurane, are known modifiable risk factors. Both excessively deep and inadequately light anesthesia can contribute to poor recovery profiles. The Bispectral Index (BIS) is an electroencephalogram (EEG)-based monitor that provides an objective measurement of a patient's level of consciousness, allowing anesthesiologists to precisely titrate anesthetic agents to an optimal depth.
This prospective, randomized controlled study was designed to investigate the role of BIS-guided anesthetic titration in mitigating the risk of ED. Upon enrollment, pediatric patients undergoing adenoidectomy and/or tonsillectomy were randomized into one of two clinical care pathways: a BIS-guided anesthesia group or a standard-care group.
To ensure baseline consistency across the study, all participants followed a standardized anesthetic induction protocol. Following routine premedication, general anesthesia was induced using inhaled sevoflurane combined with intravenous lidocaine, rocuronium (for muscle relaxation), and fentanyl (for analgesia). For the maintenance phase of anesthesia, patients in both arms received a combination of inhaled sevoflurane and continuous remifentanil infusions.
The critical divergence in the study protocol occurred during the intraoperative maintenance phase:
BIS-Guided Pathway: Anesthesiologists continuously monitored the patient's EEG activity using the BIS monitor. The concentration of the sevoflurane gas was deliberately titrated to maintain a BIS value between 40 and 60, which represents an optimal and safe depth for surgical anesthesia. By keeping patients within this precise target range, the protocol systematically avoided periods of excessively deep (BIS < 40) or overly light (BIS > 60) anesthesia.
Standard-Care Pathway: Anesthesiologists adjusted the sevoflurane concentrations based entirely on traditional clinical signs and autonomic responses, specifically monitoring hemodynamic fluctuations such as heart rate and blood pressure, without the use of EEG-guided depth parameters.
Following the completion of the surgical procedure, patients were transferred to the post-anesthesia care unit (PACU) for close observation. The clinical team systematically evaluated the patients' transition from unconsciousness to wakefulness. To ensure a robust, multi-faceted assessment of neurobehavioral status, the clinical staff utilized three validated behavioral assessment tools: the Pediatric Anesthesia Emergence Delirium (PAED) scale, the Watcha scale, and the Cravero scale. Simultaneously, postoperative physical pain was managed and tracked using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral scale.
If a patient exhibited signs meeting predetermined thresholds for severe emergence delirium (specifically, a PAED score of 10 or higher, a Watcha score of 3 to 4, or a Cravero score of 4 or higher), the clinical protocol dictated the administration of intravenous fentanyl as a rescue pharmacological intervention to safely manage the agitation.
Through this methodology, the study sought to define the relationship between strict, brain-monitored anesthetic titration and postoperative behavior. It comprehensively evaluated how preventing fluctuations in anesthetic depth impacts overall volatile anesthetic consumption, the necessity for rescue opioids in the recovery room, and the overall quality and speed of pediatric recovery following airway surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study utilized a parallel assignment model. A total of 125 pediatric patients (aged 2 to 12 years) undergoing adenoidectomy and/or tonsillectomy were randomized in a 1:1 ratio into two distinct, simultaneous arms: the intervention group (BIS-guided anesthesia) and the active comparator group (standard care). During the intraoperative phase, both groups received identical anesthetic agents (sevoflurane and remifentanil). The fundamental difference between the parallel arms was the titration strategy. In the BIS arm, sevoflurane was titrated continuously to maintain a strict Bispectral Index target of 40-60. In the standard-care arm, anesthesiologists adjusted the sevoflurane dosage based entirely on traditional clinical and hemodynamic responses, such as heart rate and blood pressure. Participants remained in their initially assigned arms for the entire duration of the surgery and the postoperative recovery observation period. No crossover design was utilized.
| Arm | Type | Receives |
|---|---|---|
| BIS-Guided Anesthesia | Experimental | Device: BIS-Guided AnesthesiaThis group received the specific intervention (the BIS monitor to guide anesthesia depth) that is the main focus of your research study. |
| Standard Care Anesthesia | Active comparator | Drug: Standard Care AnesthesiaThis group received the standard, established method of care (titrating anesthesia based on heart rate and blood pressure). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between the ages of 2 and 12 years
- Scheduled for a planned surgery to remove adenoids, tonsils, or both
- Generally healthy or having only mild medical conditions (American Society of Anesthesiologists class I or II)
- Expected to have a surgery that lasts less than 4 hours
- Having the procedure as an outpatient and expected to go home the same day
Key exclusion criteria (6 listed)
- Having severe medical conditions (American Society of Anesthesiologists class III or IV)
- Having a known history of neurological or psychiatric diseases
- Diagnosed with a developmental delay
- Having severe heart, lung, or metabolic conditions
- Having a known allergy to any of the medications used in the study
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 |
|---|---|---|
| BIS-Guided AnesthesiaAnesthetic depth was continuously guided by the Bispectral Index (BIS) monitor. A single-use BIS sensor was placed on the patient's forehead before anesthesia induction to record real-time EEG activity. The primary inhaled anesthetic (sevoflurane) was continuously titrated throughout the surgery to strictly maintain a BIS value within the target range of 40 to 60. If the BIS value dropped below 40, the sevoflurane concentration was decreased. If the BIS value exceeded 60, the continuous remifentanil infusion (0.02-0.1 mcg/kg/min) was increased first, followed by an increase in sevoflurane if necessary. Intervention | Device | BIS-Guided Anesthesia |
| Standard Care AnesthesiaAnesthetic depth was guided solely by traditional clinical signs and autonomic responses. The primary inhaled anesthetic (sevoflurane) was initiated at a 1% end-tidal concentration and adjusted in 0.25% increments (range 0.50% to 1.5%) to maintain the patient's heart rate and blood pressure within ±25% of their baseline pre-anesthesia values. Remifentanil was also infused continuously (0.02-0.1 mcg/kg/min) and adjusted based on clinical requirements. A BIS sensor was attached to the patient to record data, but the monitor screen was completely blinded to the anesthesia care provider, ensuring titration relied exclusively on standard hemodynamic metrics. | Drug | Standard Care Anesthesia |
Primary outcome
Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale
Time frame: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale ranges from a minimum of 0 to a maximum of 20. Higher scores mean a worse outcome (more severe delirium). Scores of 10 or higher were classified as a positive diagnosis for emergence delirium.
Primary Outcome Measure 2: Incidence of Emergence Delirium Assessed by the Watcha Scale
Time frame: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Evaluated postoperatively using the Watcha behavioral scale. The scale ranges from a minimum of 1 to a maximum of 4. Higher scores mean a worse outcome (greater agitation and delirium). Scores of 3 to 4 were classified as a positive diagnosis for emergence delirium.
Primary Outcome Measure 3: Incidence of Emergence Delirium Assessed by the Cravero Scale
Time frame: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Evaluated postoperatively using the Cravero behavioral scale. The scale ranges from a minimum of 1 to a maximum of 5. Higher scores mean a worse outcome (greater agitation). Scores of 4 or higher were classified as a positive diagnosis for emergence delirium.
4 secondary outcomes
Total Sevoflurane Consumption
Time frame: Intraoperative (From anesthesia induction until the completion of surgery).
Postoperative Pain Assessed by the FLACC Scale
Time frame: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Rescue Opioid Usage
Time frame: Up to 60 minutes during the post-anesthesia recovery period.
Recovery Time
Time frame: Up to 4 hours (From transfer to the recovery unit until discharge criteria were successfully met).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Emergence Delirium (Derlenme Deliryumu)
Recruiting
Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children.
Preoperative Anxiety (Ameliyat Öncesi Anksiyete), Emergence Delirium (Derlenme Deliryumu)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS-Guided Anesthesia in people with Emergence Delirium (Derlenme Deliryumu), run by Baskent University at 1 site 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 6 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: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale (time frame: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.). The study lists 3 primary outcomes in all. 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 17 Sep 2026.