Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort (NCT06399185) | Clinical Trial Compass
RecruitingPhase 4
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
China1,740 participantsStarted 2024-06-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery.