Using Dexmedetomidine and Esketamine to Reduce Bladder Discomfort from Catheters

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort in Patients Undergoing Transurethral Surgery: a 2 x 2 Factorial Randomized Trial

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
• Enrollment: 1740 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06399185 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for transurethral bladder or prostate surgery requiring a urinary catheter.

Not a fit: Patients with chronic urinary catheters or those with certain pre-existing medical conditions may not benefit from this study.

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 performed: Previous studies have shown promising results with similar approaches using dexmedetomidine and esketamine for pain management, indicating potential for success in this trial.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 1 other locations

• 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

Conditions Urinary Catheter; Catheter-related Bladder Discomfort; Dexmedetomidine; Esketamine