qNOX Response to Nociceptive Motor Events During Procedural Sedation

NCT07413848 | Recruiting

• 1 other identifier: 2025/433
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate whether the CONOX monitor can detect pain during sedation in patients undergoing urological procedures. The main questions it aims to answer are: Does the qNOX index respond to pain-related motor responses during urological procedural sedation? Does the qNOX index show greater responsiveness to painful episodes compared to blood pressure and heart rate? Participants undergoing urological procedures (such as cystoscopy) under sedation as part of their regular medical care will have continuous brain activity monitoring with the CONOX device. All monitoring displays (CONOX monitor, vital signs monitor, and target-controlled infusion pump) will be video-recorded throughout the procedure to capture synchronized data including qCON, qNOX, EMG, heart rate, blood pressure, oxygen saturation, and drug concentrations. Researchers will analyze the relationship between these indices and spontaneous movements triggered by painful stimulation to evaluate the monitor's performance compared to traditional vital signs.

Conditions

Monitoring Noxious Events Using EEG-Derived Pain Indices; Procedural Sedation and Analgesia; Monitored Anesthesia Care

Keywords

EEG Monitoring; CONOX Monitor; qNOX Index; qCON Index; Target Controlled Infusion; Procedural Sedation; Propofol

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Quantium Nociception Index (qNOX) During Motor Responses to Noxious Stimulation

  The Quantium Nociception Index (qNOX) is an electroencephalography-derived dimensionless index ranging from 0 to 99. The magnitude of change from baseline to peak qNOX value during spontaneous motor response episodes will be measured. Greater absolute change indicates better discriminative performance of the qNOX index in detecting nociception-evoked motor responses.

  During the procedure (approximately 15-60 minutes per patient)

Secondary Outcomes (4)

• Comparison of qNOX Responsiveness Versus Hemodynamic Parameters During Motor Responses

  During motor response events (if occurred) throughout the surgical procedure

• Correlation Between EMG Activity and qCON/qNOX Indices

  Throughout the surgical procedure (approximately 15-60 minutes)

• Index Dynamics During Induction and Emergence from Sedation

  Induction: 0-10 minutes; Emergence: from TCI stop until recovery of consciousness

• Incidence of Pain-Related Motor Responses During Procedural Sedation

  During the surgical procedure (approximately 15-60 minutes)

Study Arms (1)

Procedural Sedation with CONOX Monitoring

Adult patients undergoing elective urological procedures under monitored anesthesia care with continuous CONOX monitoring. All patients receive standard procedural sedation with propofol target-controlled infusion (Eleveld model) and fentanyl (1 mcg/kg), maintaining spontaneous ventilation without neuromuscular blockade. The CONOX monitor continuously records qCON, qNOX, and EMG indices throughout the procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) scheduled for elective urological procedures under monitored anesthesia care at Ankara University Faculty of Medicine. Patients will undergo standard procedural sedation with propofol target-controlled infusion and fentanyl, maintaining spontaneous ventilation without neuromuscular blockade.

You may qualify if:

• Age 18 years or older
• Scheduled for elective diagnostic or therapeutic urological procedures (cystoscopy, ureteroscopy, prostate biopsy, intradetrusor botulinum toxin injection) under monitored anesthesia care
• Able to provide written informed consent

You may not qualify if:

• Known central neurological disease (epilepsy, Alzheimer's disease, Parkinson's disease, stroke) or history of brain surgery
• Body Mass Index (BMI) ≥35 kg/m²
• Known allergy to anesthetic agents used in the study (propofol, fentanyl, lidocaine)

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Schuller PJ, Pretorius JPG, Newbery KB. Response of the Conox quantitative electroencephalographic monitor to neuromuscular block in awake volunteers. Br J Anaesth. 2025 Sep;135(3):660-667. doi: 10.1016/j.bja.2025.05.023. Epub 2025 Jul 18.

  PMID: 40683805 BACKGROUND

• Jensen EW, Valencia JF, Lopez A, Anglada T, Agusti M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4.

  PMID: 24995461 BACKGROUND

• Linassi F, Vide S, Ferreira A, Schneider G, Gambus P, Kreuzer M. Relationships between the qNOX, qCON, burst suppression ratio, and muscle activity index of the CONOX monitor during total intravenous anesthesia: a pilot study. J Clin Monit Comput. 2024 Dec;38(6):1281-1290. doi: 10.1007/s10877-024-01214-6. Epub 2024 Sep 12.

  PMID: 39266928 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Çiğdem YILDIRIM GÜÇLÜ, MD

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cahit Sefer Uçar, MD

CONTACT

+905532774107; cs.ucar@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: January 14, 2026
• Primary Completion: April 30, 2026
• Study Completion: May 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)