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临床试验/NCT07580768
NCT07580768已完成不适用

Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent: A Randomized Double-Blinded Study

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1

研究概览

简要总结

The aim of this study is to compare the efficacy of intravenous sedation using propofol alone or in combination with dexmedetomidine or midazolam for the removal of double J (D-J) ureteral stent.

详细描述

Ureteral double J (D-J) stents have been common practice in the management of various urological conditions. D-J stents are often employed to alleviate pain, prevent infection, and clear obstructions encountered during urological treatments.

Dexmedetomidine is a selective α2-adrenergic receptor agonist ( α2- AR), offering both sedation and pain relief while preserving respiratory function. Despite these benefits, one of the potential drawbacks of this medication is its tendency to lower both heart rate and blood pressure as a result of its sympatholytic properties.

Midazolam, a drug belonging to the benzodiazepines class, is commonly used for premedication before anesthesia, procedural sedation, and managing intense agitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 21 to 65 years.
  • Both sex.
  • Physical status of the patients were from I-III according to American Society of Anesthesiologists (ASA).
  • Patients underwent Double-J ureteral stent removal.

排除标准

  • Symptoms of lower urinary tract infection.
  • Stenosis of the urethra during cystoscopy.
  • Renal impairment (serum creatinine >1.5 mg/dL).
  • Chronic pain syndrome.
  • Mental disorder and difficulty in communication.
  • History of chronic use of sedatives, alcohol and narcotics.
  • Bradycardia (heart rate less than 50 beats per minute).
  • Systolic blood pressure less than 90 mm Hg.
  • Taking a sedative or analgesic 24 hours before surgery.
  • Body mass index (BMI) equal or over 35 kg/m
  • History of allergy to one of the drugs used in the study.

研究者

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

Reem Adel Hafiz

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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