Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery. [Срок оценки: Up to 24 hours after surgery.]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Peking University Shenzhen Hospital — Шэньчжэнь

Публикации

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• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06399185 · 2024-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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