qNOX monitoring of pain during procedural sedation
Official title: Performance of the CONOX Monitor Without Neuromuscular Blockade: qCON and qNOX Responses to Nociceptive Motor Events During Procedural Sedation
Run by Ankara University · NCT07413848 · Data updated 2026-11-12
This will test whether the CONOX qNOX brain-monitoring index detects pain-related movements in adults having urological procedures under sedation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Ankara University Academic / other |
| Locations | 1 site (Ankara, Altındağ) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | April 30, 2026 |
| Study ends | May 30, 2026 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT07413848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older scheduled for elective diagnostic or therapeutic urological procedures under monitored anesthesia care who can give informed consent and do not have major central neurological disease, BMI ≥35, or known allergy to the anesthetics used.
✕Probably not a fit
Patients who receive neuromuscular blockade, have major central nervous system disease, are morbidly obese (BMI ≥35), are pediatric, or who undergo non-urological or non-MAC procedures are unlikely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational single-arm cohort at Ankara University enrolling 120 adults having elective urological procedures under monitored anesthesia care without neuromuscular blockade. Continuous CONOX EEG monitoring (qCON, qNOX, EMG) plus standard vital signs and target-controlled infusion data will be video-recorded and synchronized throughout each procedure. Researchers will compare qNOX responses with observable pain-triggered motor movements and with conventional signs such as blood pressure and heart rate. The goal is to determine whether qNOX reliably signals nociception during procedural sedation and could serve as a practical bedside indicator of pain.
Why it matters
Potential benefit: If successful, qNOX could give clinicians a real-time tool to better time analgesics and potentially reduce unnecessary opioid use during procedural sedation.
How similar studies have gone: Previous CONOX/qNOX work exists but has mostly been done with neuromuscular blockade and in operating-room settings, so validation during unsuppressed motor responses in procedural sedation is relatively limited and novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where it's running
-
Ankara University
Ankara, Altındağ, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Çiğdem YILDIRIM GÜÇLÜ, MD — Ankara University
- Study coordinator: Cahit Sefer Uçar, MD
- Email: cs.ucar@hotmail.com
- Phone: +905532774107
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.