drugset / Trial / NCT06399185
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Phase 4
Recruiting
1740 enrolled
Peking University First Hospital
Peking University Shenzhen Hospital · collab
RandomizedFactorialTriple-blindTreatment
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.
Timeline
- Start
- 2024-06-06
- Primary completion
- 2027-04
- Completion
- 2027-05
Publications
- Results Anderson KE. Pharmacology of lower urinary tract smooth muscles and penile erectile tissues. Pharmacol Rev. 1993 Sep;45(3):253-308. No abstract available.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Intravenous |
| Subject | Esketamine | Other / unclassified | 0.25 mg/kg | Intravenous |