Conox-guided anesthesia for children having adenotonsillectomy
A Randomized Controlled Trial Evaluating the Effect of qCON/qNOX-Guided Anesthesia on Clinical Outcomes in Pediatric Adenotonsillectomy
This trial will test whether using Conox (qCON/qNOX) monitoring during anesthesia helps children aged 3-12 having adenotonsillectomy use less opioid and recover more smoothly after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Kayseri City Hospital Government |
| Locations | 1 site (Kayseri) |
| Trial ID | NCT07577154 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 128 children aged 3-12 with ASA I-II who are scheduled for elective adenotonsillectomy and randomize them to Conox-guided anesthesia or standard monitoring. Conox is a non-invasive EEG device that provides qCON (hypnosis) and qNOX (nociception) indices to guide anesthetic and analgesic dosing alongside routine monitoring. All participants will receive a standardized anesthesia protocol (propofol, fentanyl, rocuronium induction; sevoflurane maintenance) and the primary outcome is total intraoperative opioid consumption. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlations between qCON/qNOX values and hemodynamic measures.
Who should consider this trial
Good fit: Ideal candidates are children 3-12 years old with ASA physical status I-II scheduled for elective adenotonsillectomy whose parents or guardians can provide written informed consent and who have no acute infection or systemic disease.
Not a fit: Children with neurological disease (including epilepsy), previous pharyngeal surgery, BMI above the 95th percentile, skin or anatomical issues preventing EEG electrode placement, prior anesthesia complications, or lack of consent are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, Conox-guided anesthesia could reduce intraoperative opioid use and improve early recovery and comfort after adenotonsillectomy in children.
How similar studies have performed: EEG-guided anesthesia (for example BIS) has shown some benefits in adults, but use of Conox (qCON/qNOX) in pediatric adenotonsillectomy is relatively novel with limited prior pediatric data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Kayseri
- Kayseri Şehir Hastanesi — Kayseri, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.