Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

July 28, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1740

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
20 ml of normal saline is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Drug: Normal saline
20 ml of normal saline is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Other Names:
  • Placebo
Experimental: Dexmedetomidine group
Dexmedetomidine 0.5 μg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Drug: 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.
Experimental: Esketamine group
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.
Drug: 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.
Experimental: Dexmedetomidine-esketamine group
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery.
Time Frame: Up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of CRBD at various time points within 24 hours after surgery.
Time Frame: Up to 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.
Severity of CRBD at various time points within 24 hours after surgery.
Time Frame: Up to 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.
Intensity of pain at various time points within 24 hours after surgery.
Time Frame: Up to 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.
Subjective sleep quality on the night of surgery.
Time Frame: On the morning of the first postoperative day (8:00-10:00).
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).
Patient satisfaction at 6 hours after surgery.
Time Frame: 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.
Anxiety at hospital discharge or 2 days after surgery.
Time Frame: Up 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.
Depression at hospital discharge or 2 days after surgery.
Time Frame: Up 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.
Sleep quality at 30 days after surgery.
Time Frame: 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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay after surgery.
Time Frame: Up to 30 days after surgery.
Length of hospital stay after surgery.
Up to 30 days after surgery.
Sedation or agitation score at various time points within 24 hours after surgery.
Time Frame: Up to 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.
Use of rescue medications within 24 hours after surgery
Time Frame: Up to 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.
Duration of urinary catheterization after surgery.
Time Frame: Up to 30 days after surgery.
Postoperative catheterization time
Up to 30 days after surgery.
Occurrence of postoperative complications.
Time Frame: Up to 30 days after surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University Shenzhen Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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