NCT06399185 Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
| NCT ID | NCT06399185 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Urinary Catheter |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,740 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,740 participants in total. It began in 2024-06-06 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Catheter-related bladder discomfort (CRBD) is common in patients awaking from general anesthesia with an urinary catheter. We suppose that that use of dexmedetomidine and/or esketamine during anesthesia may reduce the occurrence of CRBD. This 2x2 factorial randomized trial is designed to explore the effects of esketamine, dexmedetomidine, and their combination on the occurrence CRBD in patients undergoing transurethral urological surgery.
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.
Contact & Investigator
Dong-Xin Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06399185 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urinary Catheter. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06399185 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06399185 currently recruiting?
Yes, NCT06399185 is actively recruiting participants. Contact the research team at zhangrui_bjmu@163.com for enrollment information.
Where is the NCT06399185 trial being conducted?
This trial is being conducted at Beijing, China, Shenzhen, China.
Who is sponsoring the NCT06399185 clinical trial?
NCT06399185 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, MD, PhD at Peking University First Hospital. The trial plans to enroll 1,740 participants.