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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Normal saline
Drug20 ml of normal saline is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Dexmedetomidine
DrugDexmedetomidine 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
DrugEsketamine 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
DrugDexmedetomidine 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.
Treatment groups
1,740 Participants
are divided into 4 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: Dexmedetomidine groupExperimental treatment 1 intervention
Group C: Esketamine groupExperimental treatment 1 intervention
Group D: Dexmedetomidine-esketamine groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of catheter-related bladder discomfort (CRBD) within 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).
Time frame
Up to 24 hours after surgery.Secondary outcomes
1
Prevalence of CRBD at various time points within 24 hours after surgery.
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). A moderate or severe CRBD is defined as occurrence of CRBD.
Time frame
Up to 24 hours after surgery.2
Severity of CRBD at various time points within 24 hours after surgery.
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).
Time frame
Up to 24 hours after surgery.3
Intensity of pain at various time points within 24 hours after surgery.
Pain intensity both at rest and with movement is assessed with a numeric rating scale (an 11-point scale where 0=no pain and 10=the worst pain) at 0 hour (arriving post-anesthesia care unit), 1 hour, 2 hours, 6 hours, and 24 hours after surgery.
Time frame
Up to 24 hours after surgery.4
Subjective sleep quality on the night of surgery.
Subjective sleep quality is assessed with a numeric rating scale (an 11-point scale where 0=the best sleep and 10=the worst sleep) on the morning of the first postoperative day (8:00-10:00).
Time frame
On the morning of the first postoperative day (8:00-10:00).Other outcomes
1
Sedation or agitation score at various time points within 24 hours after surgery.
Sedation or agitation score is assess with the Richmond Agitation-Sedation Scale (scores range from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calm) at 0 hour (arriving post-anesthesia care unit), 1 hour, 2 hours, 6 hours, and 24 hours after surgery.
Time frame
Up to 24 hours after surgery.2
Use of rescue medications within 24 hours after surgery
Rescue medications include opioids, non-steroid anti-inflammatory drugs, M-receptor blockers (totorodine, sorinaxin, mirabelon), and other analgesics for CRBD.
Time frame
Up to 24 hours after surgery.3
Duration of urinary catheterization after surgery.
Postoperative catheterization time
Time frame
Up to 30 days after surgery.4
Length of hospital stay after surgery.
Length of hospital stay after surgery.
Time frame
Up to 30 days after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University Shenzhen Hospital
Collaborator
Source ClinicalTrials.gov