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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kayseri, Tyrkiet (Türkiye)
- Rekruttering
- Kayseri Şehir Hastanesi
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Kontakt:
- ÇİĞDEM ÜNAL KANTEKİN
- Telefonnummer: +903523157700 +905054433056
- E-mail: drcgdm@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Total Intraoperative Opioid Consumption
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AT-QCON-2026-HT01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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