Using Dexmedetomidine and Esketamine to Reduce Bladder Discomfort from Catheters
Official title: Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort in Patients Undergoing Transurethral Surgery: a 2 x 2 Factorial Randomized Trial
Run by Peking University First Hospital · NCT06399185 · Data updated 2026-11-12
This study is testing if the combination of two medications, dexmedetomidine and esketamine, can help reduce bladder discomfort caused by catheters in patients having urological surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1740 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | June 6, 2024 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT06399185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for transurethral bladder or prostate surgery requiring a urinary catheter.
✕Probably not a fit
Patients with chronic urinary catheters or those with certain pre-existing medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of dexmedetomidine and esketamine on catheter-related bladder discomfort (CRBD) in patients undergoing transurethral urological surgery. It employs a 2x2 factorial design to assess the efficacy of these medications, both individually and in combination, in reducing the incidence of CRBD after surgery. The study aims to improve patient comfort and satisfaction by potentially decreasing the pain and discomfort associated with urinary catheters post-anesthesia. Participants will be monitored for CRBD symptoms and overall recovery outcomes.
Why it matters
Potential benefit: If successful, this study could significantly enhance patient comfort and satisfaction during the postoperative period by reducing catheter-related bladder discomfort.
How similar studies have gone: Previous studies have shown promising results with similar approaches using dexmedetomidine and esketamine for pain management, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or above; * Scheduled to undergo transurethral bladder or prostate surgery (including transurethral resection of bladder tumor, transurethral resection of prostate, and transurethral thulium laser prostatectomy) under general anesthesia; * Required postoperative retention of a three-chamber urinary catheter. Exclusion Criteria: * Indwelling urinary catheters or chronic analgesic therapy for ≥1 month before surgery; * Uncontrolled hypertension before surgery (resting ward systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg); * Severe bradycardia (heart rate ≤50 beats per minute), sick sinus syndrome, or atrioventricular block of degree II or above without pacemaker, or having myocardial infarction, severe heart insufficiency (New York Heart Association class ≥3), or tachyarrhythmia within a year; * Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension; * Preoperative history of hyperthyroidism and pheochromocytoma; * Inability to communicate due to coma, severe dementia, or language barrier before surgery; * Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (receiving dialysis before surgery), or Amercian Society of Anesthesiologists classification ≥IV; * Scheduled admission to the intensive care unit with endotracheal intubation after surgery; * Other conditions that are considered unsuitable for study participation.
Where it's running
-
Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China Recruiting
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Rui Zhang, MD
- Email: zhangrui_bjmu@163.com
- Phone: +8618810662529
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Intranasal dexmedetomidine‑esketamine for pain relief after adenoid and tonsil surgery in children
This trial will test whether giving children aged 3–7 a combined dexmedetomidine and esketamine nasal dose reduces pain after adenoid and tonsil surgery.
-
Dexmedetomidine and esketamine given around surgery to improve recovery after general anesthesia
This trial will test whether giving dexmedetomidine, esketamine, or both during the perioperative period helps adults recover better after surgery under general anesthesia.
-
Remimazolam, dexmedetomidine, or esketamine to calm young children before surgery
This trial will test which of three drugs—remimazolam, dexmedetomidine, or esketamine—best calms children aged 2–5 before adenotonsillectomy and reduces postoperative agitation.
-
Combining dexmedetomidine and esketamine to improve sleep after major surgery
This study is testing whether a mix of two medications, dexmedetomidine and esketamine, can help adults sleep better after major surgery compared to a placebo.
-
Using dexmedetomidine and esketamine for sedation in young children before surgery
This study tests if a combination of two medications, dexmedetomidine and esketamine, can help young children feel calm and relaxed before surgery.
-
Esketamine dose levels combined with dexmedetomidine to reduce pain after scoliosis correction
This study will test whether different doses of esketamine given with dexmedetomidine and opioids can reduce immediate postoperative pain and lower the chance of chronic postsurgical pain in adults having scoliosis correction.
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.