AnaesthesiaANIGAPPNCT07245654
Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients
An observational study of Anaesthesia and Anesthesia Depth Monitoring, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Perioperative assessment of adequate depth of anesthesia and analgesia is currently a recommended part of routine anesthesia practice for all surgical procedures. In most cases, it is performed by monitoring and evaluating physiological parameters, which is insufficient, especially for the depth of anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Anaesthesia, Anesthesia Depth Monitoring
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Nov 2025to 31 Dec 2026
- Phase
- Observational
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: - Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation) with expected duration of surgery more than 30 minutes
Who may be able to join
- Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation)
- CONOX monitoring available
Who cannot join
- Age out of range
- Use of ketamine during anesthesia care (premedication, analgesic, anesthetic)
- Expected duration of surgery less than 30 minutes
- CONOX monitoring unavailable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients: a Prospective Observational Study
Perioperative assessment of adequate depth of anesthesia and analgesia is currently a recommended part of routine anesthesia practice for all surgical procedures. In most cases, it is performed by monitoring and evaluating physiological parameters, which is insufficient, especially for the depth of anesthesia. The depth of anesthesia, when measured with the Conox device, is indicated by the qCON index, the recommended value for anesthesia management is between 40-60. Shallow (above 60) anesthesia may be associated with an increased incidence of perioperative wakefulness episodes, and deeper (below 40) anesthesia may lead to a more frequent occurrence of adverse effects of anesthesia, including emergent delirium in the postoperative period. In addition to assessing the depth of anesthesia, the Conox device also allows for instrumental assessment of analgesia. Inadequate analgesia increases postoperative discomfort and may contribute to an increased incidence of complications in anesthesia and during the postoperative period. Instrumental monitoring of the depth of anesthesia and analgesia increases the safety of anesthesia care. During perioperative care, periods with significant painful stimulation include not only the surgical procedure itself but also airway management during induction of general anesthesia, especially intubation. The hypothesis is - due to the significant painful stimulation during airway management during induction of anesthesia, adequate depth of anesthesia and analgesia may be insufficient and is associated with the patient's clinical response, which may be associated with the occurrence of postoperative delirium.
Read the detailed description
After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria. Pediatric patients aged 1 year to 19 years who undergo elective surgery under general anesthesia will be included in the study if the expected duration of the operation is more than 30 minutes.
Due to the observational nature of the study (no intervention, the monitoring used is a standard recommended part of anesthesia care), informed consent will not be required. Before induction of anesthesia, the electrodes of the CONOX device will be applied to the patient's forehead according to the manufacturer's recommendations and monitoring of the depth of anesthesia and analgesia will be initiated. Induction of anesthesia will be carried out according to the indications of the anesthesiologist (intravenously or by inhalation). During airway management, the depth of anesthesia and the level of analgesia and the patient's clinical response will be monitored. At the same time, the opioid analgesic used, the method of airway management and the occurrence of a burst suppression ratio will be monitored. Postoperatively, the occurrence of postoperative delirium in the recovery room will be monitored.
- Conditions
- Anaesthesia, Anesthesia Depth Monitoring
- Keywords
- depth of anesthesia, pediatric, nociception, awareness, depth of analgesia, airway management
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of anesthesia
Assessment of the depth of anesthesia, level of analgesia during airway management during induction of anesthesia, clinical response of the patient.
Measured: Perioperative/Periprocedural
Secondary outcomes (1)
contributing factors
Evaluation of the opioid analgesic used, method of airway management, the occurrence of BSR value above 0, the occurrence of postoperative delirium during recovery from anesthesia.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, prof.MD.Ph.D, Principal investigator, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245654
- Sponsor's protocol ID
- KDAR 2025 ANIGAPP
- Acronym
- ANIGAPP
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07245654
- Acronym / sponsor ID
- ANIGAPP / KDAR 2025 ANIGAPP
- Conditions
- Anaesthesia, Anesthesia Depth Monitoring
- Keywords
- depth of anesthesia, pediatric, nociception, awareness, depth of analgesia, airway management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (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.
Perioperative assessment of adequate depth of anesthesia and analgesia is currently a recommended part of routine anesthesia practice for all surgical procedures. In most cases, it is performed by monitoring and evaluating physiological parameters, which is insufficient, especially for the depth of anesthesia. The depth of anesthesia, when measured with the Conox device, is indicated by the qCON index, the recommended value for anesthesia management is between 40-60. Shallow (above 60) anesthesia may be associated with an increased incidence of perioperative wakefulness episodes, and deeper (below 40) anesthesia may lead to a more frequent occurrence of adverse effects of anesthesia, including emergent delirium in the postoperative period. In addition to assessing the depth of anesthesia, the Conox device also allows for instrumental assessment of analgesia. Inadequate analgesia increases postoperative discomfort and may contribute to an increased incidence of complications in anesthesia and during the postoperative period. Instrumental monitoring of the depth of anesthesia and analgesia increases the safety of anesthesia care. During perioperative care, periods with significant painful stimulation include not only the surgical procedure itself but also airway management during induction of general anesthesia, especially intubation. The hypothesis is - due to the significant painful stimulation during airway management during induction of anesthesia, adequate depth of anesthesia and analgesia may be insufficient and is associated with the patient's clinical response, which may be associated with the occurrence of postoperative delirium.
Detailed description
After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria. Pediatric patients aged 1 year to 19 years who undergo elective surgery under general anesthesia will be included in the study if the expected duration of the operation is more than 30 minutes.
Due to the observational nature of the study (no intervention, the monitoring used is a standard recommended part of anesthesia care), informed consent will not be required. Before induction of anesthesia, the electrodes of the CONOX device will be applied to the patient's forehead according to the manufacturer's recommendations and monitoring of the depth of anesthesia and analgesia will be initiated. Induction of anesthesia will be carried out according to the indications of the anesthesiologist (intravenously or by inhalation). During airway management, the depth of anesthesia and the level of analgesia and the patient's clinical response will be monitored. At the same time, the opioid analgesic used, the method of airway management and the occurrence of a burst suppression ratio will be monitored. Postoperatively, the occurrence of postoperative delirium in the recovery room will be monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- - Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation) with expected duration of surgery more than 30 minutes
Key inclusion criteria (2 listed)
- Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation)
- CONOX monitoring available
Key exclusion criteria (4 listed)
- Age out of range
- Use of ketamine during anesthesia care (premedication, analgesic, anesthetic)
- Expected duration of surgery less than 30 minutes
- CONOX monitoring unavailable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depth of anesthesia
Time frame: Perioperative/Periprocedural
Assessment of the depth of anesthesia, level of analgesia during airway management during induction of anesthesia, clinical response of the patient.
1 secondary outcome
contributing factors
Time frame: Perioperative/Periprocedural
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Petr Štourač, prof.MD.Ph.D principal investigator
Brno University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaesthesia and Anesthesia Depth Monitoring, run by Brno University Hospital 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 2 inclusion and 4 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 24 Nov 2025. 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 Tereza Bonischova, MD (00420724253223, musilovate@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of anesthesia (time frame: Perioperative/Periprocedural). 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 24 Nov 2025.