qNOX Response to Nociceptive Motor Events During Procedural Sedation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Procedural Sedation with CONOX Monitoring

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
During motor response events (if occurred) throughout the surgical procedure
2

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.

Time frame
Throughout the surgical procedure (approximately 15-60 minutes)
3

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.

Time frame
Induction: 0-10 minutes; Emergence: from TCI stop until recovery of consciousness
4

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.

Time frame
During the surgical procedure (approximately 15-60 minutes)

Other outcomes

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