Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06399185

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Led by Peking University First Hospital · Updated on 2025-07-31

1740

Participants Needed

2

Research Sites

151 weeks

Total Duration

On this page

Sponsors

P

Peking University First Hospital

Lead Sponsor

P

Peking University Shenzhen Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or above
  • Scheduled to undergo transurethral bladder or prostate surgery under general anesthesia
  • Required postoperative retention of a three-chamber urinary catheter
Not Eligible

You will not qualify if you...

  • Indwelling urinary catheters or chronic analgesic therapy for 1 month or more before surgery
  • Uncontrolled hypertension before surgery (resting systolic >180 mmHg or diastolic >110 mmHg)
  • Severe bradycardia (heart rate ≤50 beats per minute), sick sinus syndrome, or atrioventricular block of degree II or above without pacemaker
  • History of 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 American Society of Anesthesiologists classification ≥IV
  • Scheduled admission to the intensive care unit with endotracheal intubation after surgery
  • Other conditions considered unsuitable for study participation

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

2

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

R

Rui Zhang, MD

CONTACT

L

Li Huaijin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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