Emergence Delirium, AnesthesiaNCT07534215
The Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children
A study testing EEG monitoring and BIS monitoring in people with Emergence Delirium, Anesthesia, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Emergence Delirium, Anesthesia
- What is being tested?
- EEG monitoring and BIS monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2026to Dec 2028
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient aged 1-6 years indicated for surgery (hernioplasty, orchidopexy)
- Consent of parents/legal guardians
- Health status corresponding to ASA (American Society of Anesthesiologists) I and II
Who cannot join
- Disagreement of parents/legal guardians with inclusion in the study
- Neurological disease, severe hearing and vision impairment
- Health status corresponding to ASA (American Society of Anesthesiologists) III and above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, +42059737 ext. 2587, jiri.hyncica@fno.cz
Vilém Novák, MD, Ph.D.
About this study
Official title: Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children.
Read the detailed description
Preoperative preparation and the method of administering general anaesthesia will be conducted based on a standardised protocol. Each patient included in the study will be administered sedative premedication Midazolam at a dose of 0.5mg/kg per os 45-60 minutes before the operation. During transfer to the operating room, Parental Separation Anxiety Scale (PSAS) and Modified Yale Preoperative Anxiety Scale (m-YPAS) will be evaluated to assess the level of preoperative anxiety as a risk factor for emergent delirium (ED). Inhalation induction of general anaesthesia with a flow rate of 4l/min O2:air with Fio2 0.5 to achieve sufficient depth of general anaesthesia, followed by provision of peripheral venous catheter, administration of Sufentanil at a dose of 0.2uq/kg and Paracetamol 15mg/kg. Airways will be secured preferentially by a laryngeal mask, in case of leakage or the nature of the procedure by orotracheal intubation. After ensuring the airways, the gas flow is reduced to 2.5%. Immediately in the electroencephalography (EEG) group, a trained nurse connects the EEG and initiates monitoring with titration of Sevoflurane to achieve a sufficient depth of unconsciousness, which will be assessed by an EEG specialist.
In the Bispectral Index (BIS) group, the child will be equipped with a BIS electrode and the depth of general anaesthesia will be controlled with the aim of BIS values of 40-60.
The time from the start of the connection to the start of the measurement of the depth of anaesthesia, the total duration of the operation and anaesthesia will also be recorded.
During anaesthesia, in addition to vital functions, the concentration of the anaesthetic and its consumption, signs of insufficient depth of general anaesthesia will be recorded In the recovery room, scales to determine the presence of emergent delirium will be assessed - Paediatric Anesthesia Emergence Delirium scale (PAED) and Watcha scale, as well as Face, Legs, Activity, Cry, Consolability scale (FLACC) and other parameters.
- Conditions
- Emergence Delirium, Anesthesia
- Being tested
- EEG monitoring, BIS monitoring
- Keywords
- Emergence Delirium, EEG, Bispectral Index, General anaesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDiagnostic test
EEG monitoring will be performed during anaesthesia.
BIS monitoringDiagnostic test
BIS monitoring will be performed during anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| EEG monitoring | Experimental | Study subjects randomised into this arm will undergo EEG monitoring during anaesthesia. Receives: Diagnostic Test: EEG monitoring |
| BIS monitoring | Experimental | Study subjects randomised into this arm will undergo BIS monitoring during anaesthesia. Receives: Diagnostic Test: BIS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of ED (in EEG and BIS groups) - PAED scale
The presence of emergence delirium in the EEG and BIS groups will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at the recovery room. The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a 5-item, validated observational tool used to measure the severity of delirium in children during anesthesia recovery, with scores >10-12 indicating significant emergence delirium (ED).
Measured: 2 hours after surgery
Presence of ED (in EEG and BIS groups) - Watcha scale
The presence of emergence delirium in the EEG and BIS groups will be assessed using the Watcha scale at the recovery room. The Watcha scale is a simple 4-point observational tool used to assess pediatric emergence delirium (ED) (agitation or confusion) as children wake up from general anesthesia. It measures the severity of agitation, with scores >2 generally indicating significant agitation or delirium.
Measured: 2 hours after surgery
Presence of ED (in EEG and BIS groups) - FLACC scale
The presence of emergence delirium in the EEG and BIS groups will be assessed using the FLACC scale at the recovery room. The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a behavioral tool designed to measure pain in infants, young children (2 months to 7 years), and non-verbal patients. It evaluates five behaviors, scoring each from 0-2, for a total score of 0-10, where higher scores indicate greater pain.
Measured: 2 hours after surgery
Secondary outcomes (5)
Safety of EEG and BIS monitoring in relation to ED - heart rate
The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of heart rate during anaesthesia and measured in beats per minute.
Measured: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - blood pressure
The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of blood pressure during anaesthesia and measured in millimetres of mercury (mmHg).
Measured: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient movement
The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of presence of patient movement during anaesthesia (Yes/No).
Measured: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient sweating
The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of presence of patient sweating during anaesthesia (Yes/No).
Measured: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient lacrimation
The safety of EEG and BIS monitoring in relation to ED will be assessed using the monitoring of presence of patient lacrimation during anaesthesia (Yes/No).
Measured: During general anaesthesia, up to 2 hours
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 start1 Jan 2026
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium, 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
- The study subjects will be randomised into two study groups.
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vilém Novák, MD, Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534215
- Sponsor's protocol ID
- BisEEg study
- Other IDs
- 17/RVO-FNOs/2026
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
- ClinicalTrials.gov ID
- NCT07534215
- Acronym / sponsor ID
- BisEEg study
- Conditions
- Emergence Delirium, Anesthesia
- Keywords
- Emergence Delirium, EEG, Bispectral Index, General anaesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (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.
The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children.
Detailed description
Preoperative preparation and the method of administering general anaesthesia will be conducted based on a standardised protocol. Each patient included in the study will be administered sedative premedication Midazolam at a dose of 0.5mg/kg per os 45-60 minutes before the operation. During transfer to the operating room, Parental Separation Anxiety Scale (PSAS) and Modified Yale Preoperative Anxiety Scale (m-YPAS) will be evaluated to assess the level of preoperative anxiety as a risk factor for emergent delirium (ED). Inhalation induction of general anaesthesia with a flow rate of 4l/min O2:air with Fio2 0.5 to achieve sufficient depth of general anaesthesia, followed by provision of peripheral venous catheter, administration of Sufentanil at a dose of 0.2uq/kg and Paracetamol 15mg/kg. Airways will be secured preferentially by a laryngeal mask, in case of leakage or the nature of the procedure by orotracheal intubation. After ensuring the airways, the gas flow is reduced to 2.5%. Immediately in the electroencephalography (EEG) group, a trained nurse connects the EEG and initiates monitoring with titration of Sevoflurane to achieve a sufficient depth of unconsciousness, which will be assessed by an EEG specialist.
In the Bispectral Index (BIS) group, the child will be equipped with a BIS electrode and the depth of general anaesthesia will be controlled with the aim of BIS values of 40-60.
The time from the start of the connection to the start of the measurement of the depth of anaesthesia, the total duration of the operation and anaesthesia will also be recorded.
During anaesthesia, in addition to vital functions, the concentration of the anaesthetic and its consumption, signs of insufficient depth of general anaesthesia will be recorded In the recovery room, scales to determine the presence of emergent delirium will be assessed - Paediatric Anesthesia Emergence Delirium scale (PAED) and Watcha scale, as well as Face, Legs, Activity, Cry, Consolability scale (FLACC) and other parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be randomised into two study groups.
| Arm | Type | Receives |
|---|---|---|
| EEG monitoring | Experimental | Diagnostic Test: EEG monitoringStudy subjects randomised into this arm will undergo EEG monitoring during anaesthesia. |
| BIS monitoring | Experimental | Diagnostic Test: BIS monitoringStudy subjects randomised into this arm will undergo BIS monitoring during anaesthesia. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient aged 1-6 years indicated for surgery (hernioplasty, orchidopexy)
- Consent of parents/legal guardians
- Health status corresponding to ASA (American Society of Anesthesiologists) I and II
Key exclusion criteria (3 listed)
- Disagreement of parents/legal guardians with inclusion in the study
- Neurological disease, severe hearing and vision impairment
- Health status corresponding to ASA (American Society of Anesthesiologists) III and above
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 |
|---|---|---|
| EEG monitoringEEG monitoring will be performed during anaesthesia. | Diagnostic test | EEG monitoring |
| BIS monitoringBIS monitoring will be performed during anaesthesia. | Diagnostic test | BIS monitoring |
Primary outcome
Presence of ED (in EEG and BIS groups) - PAED scale
Time frame: 2 hours after surgery
The presence of emergence delirium in the EEG and BIS groups will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at the recovery room. The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a 5-item, validated observational tool used to measure the severity of delirium in children during anesthesia recovery, with scores >10-12 indicating significant emergence delirium (ED).
Presence of ED (in EEG and BIS groups) - Watcha scale
Time frame: 2 hours after surgery
The presence of emergence delirium in the EEG and BIS groups will be assessed using the Watcha scale at the recovery room. The Watcha scale is a simple 4-point observational tool used to assess pediatric emergence delirium (ED) (agitation or confusion) as children wake up from general anesthesia. It measures the severity of agitation, with scores >2 generally indicating significant agitation or delirium.
Presence of ED (in EEG and BIS groups) - FLACC scale
Time frame: 2 hours after surgery
The presence of emergence delirium in the EEG and BIS groups will be assessed using the FLACC scale at the recovery room. The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a behavioral tool designed to measure pain in infants, young children (2 months to 7 years), and non-verbal patients. It evaluates five behaviors, scoring each from 0-2, for a total score of 0-10, where higher scores indicate greater pain.
5 secondary outcomes
Safety of EEG and BIS monitoring in relation to ED - heart rate
Time frame: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - blood pressure
Time frame: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient movement
Time frame: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient sweating
Time frame: During general anaesthesia, up to 2 hours
Safety of EEG and BIS monitoring in relation to ED - patient lacrimation
Time frame: During general anaesthesia, up to 2 hours
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 21 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers. The data may be provided upon reasonable request.
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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.
Vilém Novák, MD, Ph.D. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG monitoring and BIS monitoring in people with Emergence Delirium, Anesthesia, run by University Hospital Ostrava at 1 site in Czechia.
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 3 inclusion and 3 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 21 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 1 site in Czechia. 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 Jiří Hynčica (+42059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of ED (in EEG and BIS groups) - PAED scale (time frame: 2 hours after surgery). 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 21 Apr 2026.