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Urinary CatheterPhase 4NCT06399185

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

A Phase 4 study testing Normal saline, Dexmedetomidine and Esketamine in people with Urinary Catheter and Catheter-related Bladder Discomfort, run by Peking University First Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Normal saline, Dexmedetomidine and Esketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,740 participants
Where
2 sitesChina
Study dates
6 Jun 2024to May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Zhang, MD contact

+8618810662529

zhangrui_bjmu@163.com

Li Huaijin, MD contact

+8613488659162

crystal_35@163.com

China2 sites, 2 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Rui Zhang, MD, +86 18810662529, zhangrui_bjmu@163.com

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Tao Luo, MD, 496855048@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Normal saline, Dexmedetomidine, Esketamine, Combined dexmedetomidine-esketamine
Keywords
Urinary Catheter, Catheter-related Bladder Discomfort, Dexmedetomidine, Esketamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal salineDrug

    Also called Placebo

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

  • DexmedetomidineDrug

    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.

  • EsketamineDrug

    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-esketamineDrug

    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.

Study groups in NCT06399185
Study groupRoleWhat they receive
Placebo groupPlacebo comparator20 ml of normal saline is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Receives: Drug: Normal saline
Dexmedetomidine groupExperimentalDexmedetomidine 0.5 μg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Receives: Drug: Dexmedetomidine
Esketamine groupExperimentalEsketamine 0.25 mg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
Receives: Drug: Esketamine
Dexmedetomidine-esketamine groupExperimentalDexmedetomidine 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.
Receives: Drug: Combined dexmedetomidine-esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 24 hours after surgery.

Secondary outcomes (8)

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: On the morning of the first postoperative day (8:00-10:00).

  5. 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.

    Measured: At 6 hours after surgery.

  6. 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).

    Measured: Up 2 days after surgery.

  7. 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.

    Measured: Up 2 days after surgery.

  8. 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.

    Measured: At 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start6 Jun 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
1,740 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06399185
Sponsor's protocol ID
2024-105
Status last verified
Jul 2025
First submitted
30 Apr 2024
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anderson KE. Pharmacology of lower urinary tract smooth muscles and penile erectile tissues. Pharmacol Rev. 1993 Sep;45(3):253-308. No abstract available.

    PubMed 8248281

  • Binhas M, Motamed C, Hawajri N, Yiou R, Marty J. Predictors of catheter-related bladder discomfort in the post-anaesthesia care unit. Ann Fr Anesth Reanim. 2011 Feb;30(2):122-5. doi: 10.1016/j.annfar.2010.12.009. Epub 2011 Jan 31.

    PubMed 21277735

  • Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.

    PubMed 25335575

  • Mitobe Y, Yoshioka T, Baba Y, Yamaguchi Y, Nakagawa K, Itou T, Kurahashi K. Predictors of Catheter-Related Bladder Discomfort After Surgery: A Literature Review. J Clin Med Res. 2023 Apr;15(4):208-215. doi: 10.14740/jocmr4873. Epub 2023 Apr 28.

    PubMed 37187710

  • Moataz A, Chadli A, Wichou E, Gallouo M, Jandou I, Saber S, Serhier Z, Dakir M, Debbagh A, Aboutaieb R. [Predictors of catheter-related bladder discomfort]. Prog Urol. 2020 Dec;30(16):1045-1050. doi: 10.1016/j.purol.2020.09.014. Epub 2020 Sep 30. French.

    PubMed 33011083

  • Goger YE, Ozkent MS, Goger E, Kilinc MT, Ecer G, Piskin MM, Erol A. A randomised-controlled, prospective study on the effect of dorsal penile nerve block after TURP on catheter-related bladder discomfort and pain. Int J Clin Pract. 2021 May;75(5):e13963. doi: 10.1111/ijcp.13963. Epub 2021 Jan 11.

    PubMed 33368991

  • Wang SY, Qiu Q, Shen X. Effect of Pudendal Nerve Block on the Prevention of Postoperative Bladder Spasm and Catheter-Related Bladder Discomfort in Male Patients Undergoing Transurethral Holmium Laser Enucleation of the Prostate. Clin Interv Aging. 2022 Nov 30;17:1729-1738. doi: 10.2147/CIA.S384612. eCollection 2022.

    PubMed 36474581

  • Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.

    PubMed 18653496

  • Zhang Z, Cao Z, Xu C, Wang H, Zhang C, Pan A, Wei R, Peng S, Guo F, Wang L, Sun Y. Solifenacin is able to improve the irritative symptoms after transurethral resection of bladder tumors. Urology. 2014 Jul;84(1):117-21. doi: 10.1016/j.urology.2014.02.034. Epub 2014 Apr 29.

    PubMed 24785989

  • Zhou Z, Cui Y, Zhang X, Lu Y, Chen Z, Zhang Y. The efficacy and safety of antimuscarinics for the prevention or treatment of catheter-related bladder discomfort: a systematic review and meta-analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 14;10(1):46. doi: 10.1186/s13741-021-00217-0.

    PubMed 34903279

  • Li S, Li P, Wang R, Li H. Different interventions for preventing postoperative catheter-related bladder discomfort: a systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 Jun;78(6):897-906. doi: 10.1007/s00228-021-03251-5. Epub 2022 Feb 26.

    PubMed 35218404

  • Ramesh R, Mittal A, Agrawal S. Pharmacological interventions for reducing catheter-related bladder discomfort in patients undergoing elective surgeries under general anaesthesia: A systematic review and meta-analysis. Indian J Anaesth. 2023 Feb;67(Suppl 2):S81-S92. doi: 10.4103/ija.ija_200_22. Epub 2023 Feb 22.

    PubMed 37122936

  • Srivastava VK, Nigam R, Agrawal S, Kumar S, Rambhad S, Kanaskar J. Evaluation of the efficacy of solifenacin and darifenacin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Minerva Anestesiol. 2016 Aug;82(8):867-73.

    PubMed 27607187

  • Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.

    PubMed 16415311

  • Fox C, Smith T, Maidment I, Chan WY, Bua N, Myint PK, Boustani M, Kwok CS, Glover M, Koopmans I, Campbell N. Effect of medications with anti-cholinergic properties on cognitive function, delirium, physical function and mortality: a systematic review. Age Ageing. 2014 Sep;43(5):604-15. doi: 10.1093/ageing/afu096. Epub 2014 Jul 19.

    PubMed 25038833

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Normal saline, Dexmedetomidine and Esketamine in people with Urinary Catheter and Catheter-related Bladder Discomfort, run by Peking University First Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Zhang, MD (+8618810662529, zhangrui_bjmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery. (time frame: Up to 24 hours after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06399185, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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