Actively Recruiting

Phase Not Applicable
Age: 3Years - 12Years
All Genders
ID07577154

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

Led by Kayseri City Hospital · Updated on 2026-05-11

128

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of Conox (qCON/qNOX)-guided anesthesia on drug use and recovery outcomes in children aged 3 to 12 years undergoing adenotonsillectomy. This study focuses on whether using the Conox device, which monitors brain activity related to sedation and pain, can improve anesthesia management and postoperative recovery compared to standard monitoring methods. Participants will be randomly assigned to one of two groups: one where anesthesia is guided by the Conox monitor providing qCON and qNOX values alongside standard monitoring, and another where anesthesia is managed using conventional clinical signs like heart rate and blood pressure. All children will receive a standardized anesthesia protocol including propofol, fentanyl, rocuronium, and sevoflurane. The trial will assess opioid use during surgery and other recovery factors. Throughout the study, researchers will monitor total intraoperative opioid consumption, emergence and extubation times, postoperative agitation, pain scores, and the relationship between Conox readings and vital signs. The trial aims to improve anesthetic drug use and recovery safety in pediatric adenotonsillectomy. Participation includes standard anesthesia care with additional monitoring and assessments during surgery and recovery.

CONDITIONS

Brief Title

Conox-Guided Anesthesia in Pediatric Adenotonsillectomy

Who Can Participate

Age: 3Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of surgery and anesthesia

Participants undergo anesthesia guided either by the Conox monitor with EEG-based indices or by standard clinical parameters during adenotonsillectomy surgery.

1 visit (in-person, surgery day)

Post-operative Follow-up

Duration - Up to several hours post-surgery

Participants are monitored for recovery outcomes including emergence time, extubation time, postoperative agitation, and pain scores after surgery.

Approximately 1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Kayseri Şehir Hastanesi

Kayseri, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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