Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Normal saline
- Dexmedetomidine
- Esketamine
- Combined dexmedetomidine-esketamine
Treatment groups
1,740 Participants
are divided into 4 treatment groupsSponsors and collaborators
Peking University First Hospital
Lead sponsor
Peking University Shenzhen Hospital
Collaborator
Source ClinicalTrials.gov