跳至主要内容
临床试验/NCT06399185
NCT06399185招募中4 期

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

Peking University First Hospital2 个研究点 分布在 1 个国家目标入组 1,740 人开始时间: 2024年6月6日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
1,740
试验地点
2
主要终点
Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Placebo group

Placebo Comparator

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

干预措施: Normal saline (Drug)

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.

干预措施: Dexmedetomidine (Drug)

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.

干预措施: Esketamine (Drug)

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.

干预措施: Combined dexmedetomidine-esketamine (Drug)

结局指标

主要结局

Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery.

时间窗: 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).

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Xin Wang

Professor

Peking University First Hospital

研究点 (2)

Loading locations...

相似试验