Performance of the CONOX Monitor Without Neuromuscular Blockade: qCON and qNOX Responses to Nociceptive Motor Events During Procedural Sedation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline in Quantium Nociception Index (qNOX) During Motor Responses to Noxious Stimulation
研究概览
简要总结
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.
详细描述
STUDY RATIONALE
Adequate monitoring of sedation depth and nociception is essential during monitored anesthesia care (MAC). While processed EEG monitors assess hypnotic depth, monitoring pain remains challenging. The CONOX monitor uniquely provides two indices: qCON for sedation depth and qNOX for nociception probability.
Most CONOX studies have used neuromuscular blockade, which prevents motor responses and limits validation of the qNOX index against observable pain reactions. Furthermore, data during procedural sedation and MAC is limited. The absence of neuromuscular blockade during MAC allows studying the relationship between qNOX values and actual pain-triggered motor responses, providing a concrete reference for nociception assessment.
This study evaluates whether an EEG-based nociception index can reliably detect pain when motor responses are not suppressed. If the qNOX index demonstrates adequate performance, it could provide clinicians with a tool for optimizing analgesic administration while minimizing opioid consumption.
STUDY DESIGN
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
结局指标
主要结局
Change from Baseline in Quantium Nociception Index (qNOX) During Motor Responses to Noxious Stimulation
时间窗: During the procedure (approximately 15-60 minutes per patient)
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.
次要结局
- 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))
研究者
CIGDEM YILDIRIM GUCLU
Professor of Anesthesiology and Reanimation
Ankara University