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临床试验/NCT04314050
NCT04314050已完成不适用

Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery

Ankara Diskapi Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年3月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
1
主要终点
the severity of CRBD

研究概览

简要总结

The investigators aimed to compare the effects of tramadol and dexmedetomidine, which are commonly used in anesthesia, on preventing catheter-related bladder discomfort.

详细描述

Urinary catheterization is an attempt frequently used in many surgeries, emergency services or intensive care units, especially urinary surgeries to facilitate urine output or evaluate urine output. However, as a result of urinary catheter application, most patients may develop some symptoms like pain, burning sensation and the urge to urinate constantly in the suprapubic region that the investigators call this catheter-related bladder discomfort (CRBD).

The incidence of CRBD can increase 47 to 90% in the postoperative period. The main reason of CRBD is involuntary contractions caused by muscarinic receptors, especially type 3 (M3) receptors. Therefore, antimuscarinic drugs are used to prevent and treat CRBD. Studies have shown that many drugs such as ketamine, tolterodine, oxybutynin, gabapentin, pregabalin, butylscopolamine, tramadol, dexmedetomidine are effective in preventing CRBD. Their common feature is antimuscarinic effects. However, no definitive conclusion could be reached for routine use, due to the low number of samples in the studies, surgical differences or some anticholinergic and sedative side effects. Additionally, oxybutynin, tolterodine, gabapentin, and pregabalin are only preoperatively administered orally. So more research is needed to find the ideal agent to prevent CRBD.

Tramadol is frequently used for moderate pain in surgeries. It is a centrally acting synthetic opioid analgesic that has an inhibitory effect on M1 and M3 muscarinic receptors. Tramadol has proven to be effective in reducing the severity and frequency of ICBR in intraoperative use. However, like other opioids, it can have side effects such as nausea-vomiting and sedation.

Dexmedetomidine is a selective alpha-2 adrenoceptor agonist that has analgesic, sympatholytic and sedative properties. In recent studies, it has been reported that dexmedetomidine is associated with the pathophysiology of CRBD by inhibiting type-3 (M3) muscarinic receptor which has beneficial effects in preventing CRBD in intraoperative use. Dexmedetomidine decreases the frequency of CRBD by 30%.

The first purpose of the study is to compare the effects of dexmedetomidine and tramadol on CRBD. Secondarily, the investigators aimed to compare them for their side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients between the ages of 18 and 70 years
  • American Society of Anesthesiologists I or II
  • Scheduled to undergo retrograde intrarenal surgery
  • Scheduled to apply urinary catheter intraoperatively

排除标准

  • History of bladder outlet obstruction (Bening prostatic hypertrophy)
  • History of neurogenic bladder
  • History of psychiatric illness
  • Obese patient
  • Patients whose urinary catheter cannot be inserted
  • Patients who had previously urinary catheters

研究组 & 干预措施

tramadol

Active Comparator

1,5 mg /kg tramadol will perform intraoperatively in 100 ml saline within 15 minutes at 30 minutes before surgery completed. In addition, 1 gr paracetamol will be given intraoperatively.

干预措施: Tramadol (Drug)

dexmedetomidine

Active Comparator

1 mcg/kg dexmedetomidine bolus will perform after anesthesia induction and followed by infusion of 0.5 mcg/kg/h until 30 minutes before surgery completed. In addition, 1 gr paracetamol will be given intraoperatively.

干预措施: Dexmedetomidine (Drug)

control

Placebo Comparator

1 gr paracetamol will perform intraoperatively

干预措施: control (Other)

结局指标

主要结局

the severity of CRBD

时间窗: 6. hour

none - mild- moderate- severe

次要结局

  • 11-point numerical rating scale (NRS)(24 hours)

研究者

发起方
Ankara Diskapi Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Özkan Sipahioğlu

University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Department of Anesthesiology and Reanimation

Ankara Diskapi Training and Research Hospital

研究点 (1)

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