Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06399185
• Other study ID #: 2024-105
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2024
• Est. completion date: May 2027

Study information

• Verified date: June 2024
• Source: Peking University First Hospital
• Contact: Rui Zhang, MD
• Phone: +8618810662529
• Email: zhangrui_bjmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1740
• Est. completion date: May 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter-related Bladder Discomfort
• Dexmedetomidine
• Esketamine
• Urinary Catheter

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 24 hours after surgery.
Other	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.	Up to 24 hours after surgery.
Other	Duration of urinary catheterization after surgery.	Postoperative catheterization time	Up to 30 days after surgery.
Other	Length of hospital stay after surgery.	Length of hospital stay after surgery.	Up to 30 days after surgery.
Other	Occurrence of postoperative complications.	Postoperative complications are defined as newly occurred conditions that are deemed harmful to patients' recovery and required medical interventions, i.e., grade II or higher on Clavien-Dindo classification.	Up to 30 days after surgery.
Primary	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).	Up to 24 hours after surgery.
Secondary	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.	Up to 24 hours after surgery.
Secondary	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).	Up to 24 hours after surgery.
Secondary	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.	Up to 24 hours after surgery.
Secondary	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).	On the morning of the first postoperative day (8:00-10:00).
Secondary	Patient satisfaction at 6 hours after surgery.	Patients' satisfaction with CRBD control is evaluated with a 7-point Likert scale: 1=very dissatisfied, 2=moderate dissatisfied, 3=mild dissatisfied, 4=no propensity (moderate), 5=mild satisfied, 6=moderate satisfied, 7=very satisfied.	At 6 hours after surgery.
Secondary	Anxiety at hospital discharge or 2 days after surgery.	Anxiety is assessed with Generalized Anxiety Disorder-7 (scores range from 0 to 21, with higher score indicating more severe anxiety).	Up 2 days after surgery.
Secondary	Depression at hospital discharge or 2 days after surgery.	Depression is assessed with Patient Health Questionnaire-9 (scores range from 0 to 27, with higher score indicating more severe depression.	Up 2 days after surgery.
Secondary	Sleep quality at 30 days after surgery.	Sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI) questionnaire, scores range from 0 to 21, with higher score indicating poorer sleep quality.	At 30 days after surgery.