Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent
2026年5月5日 更新者：Reem Adel Hafiz、Tanta University
Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent: A Randomized Double-Blinded Study
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
El-Gharbia
-
Tanta、El-Gharbia、埃及、31527
- Tanta University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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/m2.
- History of allergy to one of the drugs used in the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Group P (Propofol alone)
Patients received 10 ml of normal saline injected intravenous within 10 min then intravenous propofol titrated with normal saline and injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
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Patients received 10 ml of normal saline injected intravenous within 10 min then intravenous propofol titrated with normal saline and injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
|
|
实验性的：Group D (Propofol and Dexmedetomidine)
Patients received dexmedetomidine 1 µg/kg intravenous titrated with 10 ml of normal saline injected within 10 min prior to propofol administration by 10 min.
Propofol was injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs
|
Patients received dexmedetomidine 1 µg/kg intravenous titrated with 10 ml of normal saline injected within 10 min prior to propofol administration by 10 min.
Propofol was injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
|
|
实验性的：Group M (Propofol and Midazolam)
Patients received midazolam 0.05 mg/kg titrated with 10 ml of normal saline injected intravenous within 10 min prior to propofol administration by 10 min.
Propofol was injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
|
Patients received midazolam 0.05 mg/kg titrated with 10 ml of normal saline injected intravenous within 10 min prior to propofol administration by 10 min.
Propofol was injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total propofol consumption
大体时间：Intraoperatively
|
Total propofol consumption was recorded.
|
Intraoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sedation level
大体时间：30 minutes in the recovery area
|
Sedation level was assessed preoperatively, every 5 minutes during the procedure and every 10 min during stay in the recovery area by Ramsay sedation scale classified 1-6 (1= anxious, 2= calm,3= lethargic, 4= confused and responsive to auditory stimuli, 5= sluggish response to auditory stimuli, 6= No response to painful stimuli)
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30 minutes in the recovery area
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Degree of patient satisfaction
大体时间：24 hours postoperatively
|
Degree of patient satisfaction was assessed by using a 5 point Likert scale as follows 1. extremely dissatisfied; 2. unsatisfied; 3. neutral; 4. satisfied; 5. extremely satisfied
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24 hours postoperatively
|
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Duration of stay in the recovery area
大体时间：30 minutes in the recovery area
|
Duration of stay in the recovery area was recorded.
|
30 minutes in the recovery area
|
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Incidence of complications
大体时间：24 hours postoperatively
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Incidence of complications such as apnea, laryngospasm, hypotension, bradycardia, nausea, vomiting, or any other complication were recorded.
|
24 hours postoperatively
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年11月1日
初级完成 (实际的)
2025年10月1日
研究完成 (实际的)
2025年10月1日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 36264MS734/11/24
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享时间框架
After the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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