Premedication for ERCP With Midazolam or Tramadol
Effects of Midazolam or Tramadol Premedication on Early Cognitive Function in ERCP: a Randomized Controlled Double-Blind Study
OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde cholangiopancreatography) METHODS:This randomized and double blind study was performed with forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned. Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who were randomly divided into two premedication groups.
Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was considered as cognitive impairment. Recovery period, post-procedure state of cognitive function at 60th minute were recorded.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- This study was conducted in the Endoscopy Department for forty (18-70 years old) outpatients in ASA I-III risk group were randomized and double blind planned for elective ERCP.
Exclusion Criteria:
- American Society of Anesthesiologist (ASA) class greater than 3,
- morbid obesity,
- major organ dysfunction (respiratory, renal and hepatic),
- history of drug addiction,
- known hypersensitivity for tramadol, midazolam and remifentanil,
- mini-mental test (MMT) ≤ 23 or
- refusal of the patient.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：tramadol
1mg/kg of tramadol drop (Contramal® drop, Abdi Ibrahim Ilaç San.,istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, Group T who were separated randomly to two premedication groups.
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GROUP T
其他名称：
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有源比较器：midazolam
0.15 mg/kg of midazolam (Dormicum®, ampoule, Roche Products A.Ş., istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, to Group M who were separated randomly to two premedication groups.
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GROUP M
其他名称：
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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 |
|---|---|---|
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The early cognitive functions after ERCP
大体时间：Postprocedure in the first 60 minutes
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The early cognitive functions after ERCP assessed by mini-mental test (MMT)
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Postprocedure in the first 60 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with Adverse Events
大体时间：Postprocedure in first 60 minutes
|
With any side effects
|
Postprocedure in first 60 minutes
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合作者和调查者
调查人员
- 学习椅：Mehmet Arslan, Prof.Dr.、Gastroenterology department
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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