Adenotonsillar HypertrophyNCT07577154
Conox-Guided Anesthesia in Pediatric Adenotonsillectomy
A study testing Conox Monitor and Standard Anesthesia Monitoring in people with Adenotonsillar Hypertrophy and Postoperative Pain, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of Conox (qCON/qNOX)-guided anesthesia on intraoperative anesthetic drug consumption and postoperative outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring system that provides indices of both hypnosis and nociception. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Adenotonsillar Hypertrophy, Postoperative Pain
- What is being tested?
- Conox Monitor and Standard Anesthesia Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Sep 2026
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 12 years ASA physical status I-II Scheduled for elective adenotonsillectomy No acute infection or systemic disease Parent or legal guardian able to provide written informed consent
Who cannot join
- Skin lesions or anatomical abnormalities preventing placement of EEG electrodes History of neurological disease, including epilepsy or neurological syndromes Body mass index above the 95th percentile for age Previous pharyngeal surgery History of anesthesia-related complications Absence of written informed consent from a parent or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri Şehir Hastanesi
Kayseri
ÇİĞDEM ÜNAL KANTEKİN, +905054433056 ext. +903523157700, drcgdm@gmail.com
About this study
Official title: A Randomized Controlled Trial Evaluating the Effect of qCON/qNOX-Guided Anesthesia on Clinical Outcomes in Pediatric Adenotonsillectomy
This study aims to evaluate the effect of Conox (qCON/qNOX)-guided anesthesia on intraoperative anesthetic drug consumption and postoperative outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring system that provides indices of both hypnosis and nociception.
In this randomized controlled trial, children aged 3-12 years will be assigned to either a Conox-guided anesthesia group or a standard monitoring group. The primary outcome of the study is total intraoperative opioid consumption, assessed from anesthesia induction to the end of surgery. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlation between qCON/qNOX values and hemodynamic parameters.
Read the detailed description
This randomized controlled trial is designed to investigate the impact of Conox (qCON/qNOX)-guided anesthesia on anesthetic management and clinical outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring device that simultaneously provides indices of hypnotic depth (qCON) and nociception (qNOX), allowing for more precise anesthetic titration.
A total of 128 children aged 3-12 years with ASA physical status I-II scheduled for elective adenotonsillectomy will be enrolled. Participants will be randomized into two groups using a sealed envelope method. In the Conox group, anesthetic depth and analgesic administration will be guided by qCON and qNOX values in addition to standard monitoring. In the control group, anesthesia will be managed using conventional clinical parameters such as heart rate and mean arterial pressure.
All patients will receive a standardized anesthesia protocol including propofol, fentanyl, rocuronium for induction, and sevoflurane for maintenance. The primary outcome of the study is total intraoperative opioid consumption, assessed from anesthesia induction to the end of surgery. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlation between qCON/qNOX values and hemodynamic variables.
The study aims to determine whether Conox-guided anesthesia can optimize anesthetic drug use, improve postoperative recovery, and enhance patient safety in pediatric anesthesia practice.
- Conditions
- Adenotonsillar Hypertrophy, Postoperative Pain
- Being tested
- Conox Monitor, Standard Anesthesia Monitoring
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conox MonitorDevice
EEG-based monitoring device providing qCON and qNOX indices to guide anesthetic depth and analgesia.
Standard Anesthesia MonitoringOther
Anesthesia management based on conventional clinical parameters such as heart rate and blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Conox Group | Experimental | Patients will receive anesthesia management guided by qCON and qNOX values obtained from the Conox monitor in addition to standard monitoring. Receives: Device: Conox Monitor |
| Standard Monitoring Group | Active comparator | Patients will receive anesthesia management based on standard clinical parameters such as heart rate and mean arterial pressure without Conox guidance. Receives: Other: Standard Anesthesia Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Intraoperative Opioid Consumption
Total cumulative opioid dose administered from induction of anesthesia until the end of surgery.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenotonsillar HypertrophyStudies 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
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Çiğdem Ünal Kantekin, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577154
- Sponsor's protocol ID
- AT-QCON-2026-HT01
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effect of qCON/qNOX-Guided Anesthesia on Clinical Outcomes in Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT07577154
- Acronym / sponsor ID
- AT-QCON-2026-HT01
- Conditions
- Adenotonsillar Hypertrophy, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 11 May 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.
This study aims to evaluate the effect of Conox (qCON/qNOX)-guided anesthesia on intraoperative anesthetic drug consumption and postoperative outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring system that provides indices of both hypnosis and nociception.
In this randomized controlled trial, children aged 3-12 years will be assigned to either a Conox-guided anesthesia group or a standard monitoring group. The primary outcome of the study is total intraoperative opioid consumption, assessed from anesthesia induction to the end of surgery. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlation between qCON/qNOX values and hemodynamic parameters.
Detailed description
This randomized controlled trial is designed to investigate the impact of Conox (qCON/qNOX)-guided anesthesia on anesthetic management and clinical outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring device that simultaneously provides indices of hypnotic depth (qCON) and nociception (qNOX), allowing for more precise anesthetic titration.
A total of 128 children aged 3-12 years with ASA physical status I-II scheduled for elective adenotonsillectomy will be enrolled. Participants will be randomized into two groups using a sealed envelope method. In the Conox group, anesthetic depth and analgesic administration will be guided by qCON and qNOX values in addition to standard monitoring. In the control group, anesthesia will be managed using conventional clinical parameters such as heart rate and mean arterial pressure.
All patients will receive a standardized anesthesia protocol including propofol, fentanyl, rocuronium for induction, and sevoflurane for maintenance. The primary outcome of the study is total intraoperative opioid consumption, assessed from anesthesia induction to the end of surgery. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlation between qCON/qNOX values and hemodynamic variables.
The study aims to determine whether Conox-guided anesthesia can optimize anesthetic drug use, improve postoperative recovery, and enhance patient safety in pediatric anesthesia practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conox Group | Experimental | Device: Conox MonitorPatients will receive anesthesia management guided by qCON and qNOX values obtained from the Conox monitor in addition to standard monitoring. |
| Standard Monitoring Group | Active comparator | Other: Standard Anesthesia MonitoringPatients will receive anesthesia management based on standard clinical parameters such as heart rate and mean arterial pressure without Conox guidance. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 3 to 12 years ASA physical status I-II Scheduled for elective adenotonsillectomy No acute infection or systemic disease Parent or legal guardian able to provide written informed consent
Key exclusion criteria (1 listed)
- Skin lesions or anatomical abnormalities preventing placement of EEG electrodes History of neurological disease, including epilepsy or neurological syndromes Body mass index above the 95th percentile for age Previous pharyngeal surgery History of anesthesia-related complications Absence of written informed consent from a parent or legal guardian
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 |
|---|---|---|
| Conox MonitorEEG-based monitoring device providing qCON and qNOX indices to guide anesthetic depth and analgesia. | Device | Conox Group |
| Standard Anesthesia MonitoringAnesthesia management based on conventional clinical parameters such as heart rate and blood pressure. | Other | Standard Monitoring Group |
Primary outcome
Total Intraoperative Opioid Consumption
Time frame: Intraoperative period
Total cumulative opioid dose administered from induction of anesthesia until the end of surgery.
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 11 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conox Monitor and Standard Anesthesia Monitoring in people with Adenotonsillar Hypertrophy and Postoperative Pain, run by Kayseri City Hospital 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 1 inclusion and 1 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 11 May 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intraoperative Opioid Consumption (time frame: Intraoperative period). 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 11 May 2026.