Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

NCT06399185 | Recruiting Phase 4

• 1 other identifier: 2024-105
• Study Type: interventional
• Target: 1,740
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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).

  Up to 24 hours after surgery.

Secondary Outcomes (8)

• Prevalence of CRBD at various time points within 24 hours after surgery.

  Up to 24 hours after surgery.

• Severity of CRBD at various time points within 24 hours after surgery.

  Up to 24 hours after surgery.

• Intensity of pain at various time points within 24 hours after surgery.

  Up to 24 hours after surgery.

• Subjective sleep quality on the night of surgery.

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

• Patient satisfaction at 6 hours after surgery.

  At 6 hours after surgery.

Other Outcomes (5)

• Sedation or agitation score at various time points within 24 hours after surgery.

  Up to 24 hours after surgery.

• Use of rescue medications within 24 hours after surgery

  Up to 24 hours after surgery.

• Duration of urinary catheterization after surgery.

  Up to 30 days after surgery.

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

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

Drug: Normal saline

Dexmedetomidine group

EXPERIMENTAL

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

Esketamine group

EXPERIMENTAL

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

Dexmedetomidine-esketamine group

EXPERIMENTAL

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

Interventions

Normal saline DRUG

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

Also known as: Placebo

Placebo group

Dexmedetomidine DRUG

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.

Dexmedetomidine group

Esketamine DRUG

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.

Esketamine group

Combined dexmedetomidine-esketamine DRUG

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.

Dexmedetomidine-esketamine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Related Publications (31)

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

  PMID: 8248281 RESULT

• 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.

  PMID: 21277735 RESULT

• 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.

  PMID: 25335575 RESULT

• 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.

  PMID: 37187710 RESULT

• 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.

  PMID: 33011083 RESULT

• 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.

  PMID: 33368991 RESULT

• 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.

  PMID: 36474581 RESULT

• 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.

  PMID: 18653496 RESULT

• 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.

  PMID: 24785989 RESULT

• 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.

  PMID: 34903279 RESULT

• 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.

  PMID: 35218404 RESULT

• 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.

  PMID: 37122936 RESULT

• 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.

  PMID: 27607187 RESULT

• 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.

  PMID: 16415311 RESULT

• 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.

  PMID: 25038833 RESULT

• Oelke M, Speakman MJ, Desgrandchamps F, Mamoulakis C. Acute Urinary Retention Rates in the General Male Population and in Adult Men With Lower Urinary Tract Symptoms Participating in Pharmacotherapy Trials: A Literature Review. Urology. 2015 Oct;86(4):654-65. doi: 10.1016/j.urology.2015.06.025. Epub 2015 Jul 2.

  PMID: 26142712 RESULT

• Hur M, Park SK, Yoon HK, Yoo S, Lee HC, Kim WH, Kim JT, Ku JH, Bahk JH. Comparative effectiveness of interventions for managing postoperative catheter-related bladder discomfort: a systematic review and network meta-analysis. J Anesth. 2019 Apr;33(2):197-208. doi: 10.1007/s00540-018-2597-2. Epub 2019 Jan 2.

  PMID: 30603826 RESULT

• Takizuka A, Minami K, Uezono Y, Horishita T, Yokoyama T, Shiraishi M, Sakurai T, Shigematsu A, Ueta Y. Dexmedetomidine inhibits muscarinic type 3 receptors expressed in Xenopus oocytes and muscarine-induced intracellular Ca2+ elevation in cultured rat dorsal root ganglia cells. Naunyn Schmiedebergs Arch Pharmacol. 2007 Jul;375(5):293-301. doi: 10.1007/s00210-007-0168-4. Epub 2007 Jun 12.

  PMID: 17563882 RESULT

• Lu J, Yang X, Zhang J, Huang Y. The efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Dec 30;100(52):e28217. doi: 10.1097/MD.0000000000028217.

  PMID: 34967355 RESULT

• Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.

  PMID: 30570761 RESULT

• Lu Y, Li Q, Wang Y, Zhou Z, Zhang D, Bao Y, Wu J, Cui Y. Meta-Analysis of the Efficacy and Safety of Ketamine on Postoperative Catheter-Related Bladder Discomfort. Front Pharmacol. 2022 Jun 27;13:816995. doi: 10.3389/fphar.2022.816995. eCollection 2022.

  PMID: 35833034 RESULT

• Bartova L, Papageorgiou K, Milenkovic I, Dold M, Weidenauer A, Willeit M, Winkler D, Kasper S. Rapid antidepressant effect of S-ketamine in schizophrenia. Eur Neuropsychopharmacol. 2018 Aug;28(8):980-982. doi: 10.1016/j.euroneuro.2018.05.007. Epub 2018 Jul 2.

  PMID: 30041987 RESULT

• Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.

  PMID: 29736744 RESULT

• Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Am J Psychiatry. 2018 Jul 1;175(7):620-630. doi: 10.1176/appi.ajp.2018.17060720. Epub 2018 Apr 16.

  PMID: 29656663 RESULT

• Segmiller F, Ruther T, Linhardt A, Padberg F, Berger M, Pogarell O, Moller HJ, Kohler C, Schule C. Repeated S-ketamine infusions in therapy resistant depression: a case series. J Clin Pharmacol. 2013 Sep;53(9):996-8. doi: 10.1002/jcph.122. Epub 2013 Jul 24. No abstract available.

  PMID: 23893490 RESULT

• Persson J, Hasselstrom J, Maurset A, Oye I, Svensson JO, Almqvist O, Scheinin H, Gustafsson LL, Almqvist O. Pharmacokinetics and non-analgesic effects of S- and R-ketamines in healthy volunteers with normal and reduced metabolic capacity. Eur J Clin Pharmacol. 2002 Feb;57(12):869-75. doi: 10.1007/s002280100353.

  PMID: 11936706 RESULT

• Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.

  PMID: 37302963 RESULT

• Akca B, Aydogan-Eren E, Canbay O, Karagoz AH, Uzumcugil F, Ankay-Yilbas A, Celebi N. Comparison of efficacy of prophylactic ketamine and dexmedetomidine on postoperative bladder catheter-related discomfort. Saudi Med J. 2016 Jan;37(1):55-9. doi: 10.15537/smj.2016.1.14122.

  PMID: 26739975 RESULT

• Agarwal A, Gupta D, Kumar M, Dhiraaj S, Tandon M, Singh PK. Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study. Br J Anaesth. 2006 May;96(5):587-9. doi: 10.1093/bja/ael048. Epub 2006 Mar 10.

  PMID: 16531445 RESULT

• Agarwal A, Raza M, Singhal V, Dhiraaj S, Kapoor R, Srivastava A, Gupta D, Singh PK, Pandey CK, Singh U. The efficacy of tolterodine for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Anesth Analg. 2005 Oct;101(4):1065-1067. doi: 10.1213/01.ane.0000167775.46192.e9.

  PMID: 16192522 RESULT

• Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.

  PMID: 21818162 RESULT

MeSH Terms

Interventions

Saline Solution; Dexmedetomidine; Esketamine

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Zhang, MD

CONTACT

+8618810662529; zhangrui_bjmu@163.com

Li Huaijin, MD

CONTACT

+8613488659162; crystal_35@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)