About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Comparison of qNOX Responsiveness Versus Hemodynamic Parameters During Motor Responses
Magnitude of change in qNOX index compared to changes in heart rate, mean arterial pressure and SPI during motor responses to noxious stimulation. Assessed by comparing percentage change from baseline for each parameter.
Correlation Between EMG Activity and qCON/qNOX Indices
Relationship between electromyographic (EMG) activity levels and qCON/qNOX index values throughout the procedure. Assessed using correlation analysis between EMG and each index.
Index Dynamics During Induction and Emergence from Sedation
Rate of change (slope) in qCON (Quantium Consciousness Index, 0-99 scale), qNOX (Quantium Nociception Index, 0-99 scale), and EMG (electromyographic activity, 0-100 scale) indices during sedation induction and emergence. Induction phase: from baseline to achievement of target sedation (MOAAS ≤1) Emergence phase: from TCI cessation to return of consciousness (response to verbal commands) Slopes will be calculated as the rate of index change per unit time (index units per minute) using linear regression for each phase. This standardized measure allows comparison of dynamics across different indices despite their different physiological meanings.
Incidence of Pain-Related Motor Responses During Procedural Sedation
Proportion of patients experiencing spontaneous motor responses triggered by noxious stimulation during urological procedures under standardized anesthetic protocol. Motor responses include extremity/trunk movement, facial grimacing, or vocalization.
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