Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07577154

Conox-Guided Anesthesia 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri Şehir Hastanesi

Kayseri, Turkey (Türkiye)

Location status: Recruiting

Location contact

ÇİĞDEM ÜNAL KANTEKİN

CONTACT

[email protected]

+905054433056 ext. +903523157700

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conox Monitor

Device

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

Standard Anesthesia Monitoring

Other

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

Primary outcomes

  1. Total Intraoperative Opioid Consumption

    Time frame: Intraoperative period

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

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

A Randomized Controlled Trial Evaluating the Effect of qCON/qNOX-Guided Anesthesia on Clinical Outcomes in Pediatric Adenotonsillectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.