Clinical trial NCT06399185: Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Official title: Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort in Patients Undergoing Transurethral Surgery: a 2 x 2 Factorial Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Catheter
Catheter-related Bladder Discomfort
Dexmedetomidine
Esketamine
Keywords: Urinary Catheter
Catheter-related Bladder Discomfort
Dexmedetomidine
Esketamine
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Shenzhen Hospital
First posted: 2024-05-03
Enrollment: 1740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: Urethral catheterization is commonly used during and after surgery. However, patients with indwelling urinary catheters often present with catheter-related bladder discomfort (CRBD) after awakening from anesthesia. CRBD is characterized by pain and discomfort in the suprapubic area or symptoms like overactive bladder, characterized by frequent and urgent urination, with or without acute incontinence. The incidence of CRBD is relatively high, ranging from 47% to 90%. The development of CRBD not only reduces patients' perioperative satisfaction, but also increases the incidence of postoperative complications, affects patients' postoperative rehabilitation, and prolongs the length of hospital stay. It also increases the workload of medical staff.

The occurrence of CRBD is affected by many factors, such as gender, size of urinary tube, and type of surgery. Studies show that the use of ≥18F catheter increases the incidence of CRBD. After transurethral surgery, such as transurethral resection of bladder tumor (TUR-Bt), transurethral resection of prostate (TURP), and transurethral holmium laser resection of prostate (HoLRP), a 20F catheter is often required for bladder irrigation; the catheter carrying time may be extended for bladder perfusion. Therefore, the incidence of CRBD is higher after such operations.

Dexmedetomidine is a highly selective α2 receptor agonist with analgesic, anxiolytic, and sedative effects. Several randomized trial confirmed that intraoperative use of 0.3-1.0 μg/kg dexmedetomidine reduces the incidence and severity of postoperative CRBD, and the effect persists up to 6 hours after surgery. Ketamine is a non-competitive N-methyl-D-aspartate receptor antagonist and produces analgesic and anti-hyperalgesia effects. A recent meta-analysis found that subanesthetic doses of ketamine (0.25 mg/kg or 0.5 mg/kg) reduce the severity of CRBD within 1-2 hours after surgery and the incidence of CRBD within 2-6 hours after surgery. Esketamine is the S-enantiomer of racemic ketamine and has a higher affinity for NMDA receptors; it is twice as potent as racemic ketamine.

The investigators hypothesize that the combination of dexmedetomidine and esketamine may improve the efficacy in preventing CRBD. This 2x2 factorial trial is designed to observe the effect of dexmedetomidine, esketamine, and dexmedetomidine-esketamine combination on the occurrence of CRBD in patients following 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.

Primary outcomes:
measure: Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery.
timeFrame: Up to 24 hours after surgery.
Secondary outcomes:
measure: Prevalence of CRBD at various time points within 24 hours after surgery.
timeFrame: Up to 24 hours after surgery.
measure: Severity of CRBD at various time points within 24 hours after surgery.
timeFrame: Up to 24 hours after surgery.
measure: Intensity of pain at various time points within 24 hours after surgery.
timeFrame: Up to 24 hours after surgery.
measure: Subjective sleep quality on the night of surgery.
timeFrame: On the morning of the first postoperative day (8:00-10:00).
measure: Patient satisfaction at 6 hours after surgery.
timeFrame: At 6 hours after surgery.
measure: Anxiety at hospital discharge or 2 days after surgery.
timeFrame: Up 2 days after surgery.
measure: Depression at hospital discharge or 2 days after surgery.
timeFrame: Up 2 days after surgery.
measure: Sleep quality at 30 days after surgery.
timeFrame: At 30 days after surgery.
Other outcomes:
measure: Sedation or agitation score at various time points within 24 hours after surgery.
timeFrame: Up to 24 hours after surgery.
measure: Use of rescue medications within 24 hours after surgery
timeFrame: Up to 24 hours after surgery.
measure: Duration of urinary catheterization after surgery.
timeFrame: Up to 30 days after surgery.
measure: Length of hospital stay after surgery.
timeFrame: Up to 30 days after surgery.
measure: Occurrence of postoperative complications.
timeFrame: Up to 30 days after surgery.
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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