Conox-Guided Anesthesia in Pediatric Adenotonsillectomy
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kayseri, Turquie (Türkiye)
- Recrutement
- Kayseri Şehir Hastanesi
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Contact:
- ÇİĞDEM ÜNAL KANTEKİN
- Numéro de téléphone: +903523157700 +905054433056
- E-mail: drcgdm@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Conox Group
Patients will receive anesthesia management guided by qCON and qNOX values obtained from the Conox monitor in addition to standard monitoring.
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EEG-based monitoring device providing qCON and qNOX indices to guide anesthetic depth and analgesia.
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Comparateur actif: Standard Monitoring Group
Patients will receive anesthesia management based on standard clinical parameters such as heart rate and mean arterial pressure without Conox guidance.
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Anesthesia management based on conventional clinical parameters such as heart rate and blood pressure.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Total Intraoperative Opioid Consumption
Délai: Intraoperative period
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Total cumulative opioid dose administered from induction of anesthesia until the end of surgery.
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Intraoperative period
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AT-QCON-2026-HT01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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