Clinical trial

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort in Patients Undergoing Transurethral Surgery: a 2 x 2 Factorial Randomized Trial

Name

2024-105

Description

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.

Trial arms

Trial start

2024-06-06

Estimated PCD

2027-04-01

Trial end

2027-05-01

Status

Recruiting

Phase

Early phase I

Treatment

Normal saline

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

Arms:

Placebo group

Other names:

Placebo

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.

Arms:

Dexmedetomidine group

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.

Arms:

Esketamine group

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.

Arms:

Dexmedetomidine-esketamine group

Size

1740

Primary endpoint

Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery.

Up to 24 hours after 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1740, 'type': 'ESTIMATED'}}

Updated at

2024-06-07

1 organization

3 products

1 drug

4 indications

Organization

Peking University First Hospital

Drug

Varlilumab

Indication

Urinary Catheter