Conox-Guided Anesthesia in Pediatric Adenotonsillectomy

NCT07577154 | Recruiting

• 1 other identifier: AT-QCON-2026-HT01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adenotonsillar Hypertrophy; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total Intraoperative Opioid Consumption

  Total cumulative opioid dose administered from induction of anesthesia until the end of surgery.

  Intraoperative period

Study Arms (2)

Conox Group

EXPERIMENTAL

Patients will receive anesthesia management guided by qCON and qNOX values obtained from the Conox monitor in addition to standard monitoring.

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.

Other: Standard Anesthesia Monitoring

Interventions

Conox Monitor DEVICE

EEG-based monitoring device providing qCON and qNOX indices to guide anesthetic depth and analgesia.

Conox Group

Standard Anesthesia Monitoring OTHER

Anesthesia management based on conventional clinical parameters such as heart rate and blood pressure.

Standard Monitoring Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri Şehir Hastanesi

Kayseri, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)