Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

NCT06399185 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Phase 4

Started

2024-06-06

Last updated

2025-07-31

Condition(s) studied

Urinary CatheterCatheter-related Bladder DiscomfortDexmedetomidineEsketamine

Investigational drug(s) / intervention(s)

Normal salineDexmedetomidine →Esketamine →Combined dexmedetomidine-esketamine

Normal saline: 20 ml of normal saline is infused intravenously at 80 ml/h after anesthesia induction but before surgery.

Dexmedetomidine: Dexmedetomidine 0.5 μg/kg, diluted with normal salinet o 20 ml, is infused intravenously at 60 ml/h after anesthesia induction but before surgery.

Esketamine: Esketamine 0.25 mg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.

Combined dexmedetomidine-esketamine: Dexmedetomidine 0.5 μg/kg and esketamine 0.25 mg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery. — Up to 24 hours after surgery.
Defined as occurrence of moderate or severe CRBD at any time point within 24 hours after surgery. CRBD is a strong desire to urinate or discomfort in the pubic region that occurs after awakening from anesthesia. The occurrence of CRBD is assessed at 0 hour (arriving post-anesthesia care unit), 1 hour, 2 hours, 6 hours, and 24 hours after surgery. The severity of CRBD is divided into four levels: 1- None, even when asked, no discomfort is reported; 2- Mild, only report discomfort during questioning; 3-Moderate, reported discomfort without inquiry, but without behavioral reactions; 4-Severe, with the patient actively reporting discomfort and behavioral reactions (observable behavioral reactions include limb movement, strong vocal reactions, or attempts to remove the catheter).

Trial sites (2)

Facility	City	Region	Status
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting
Peking University Shenzhen Hospital	Shenzhen	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06399185 on ClinicalTrials.gov ↗ ← All trials in China