Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit (GADEX)
2010年6月3日 更新者：University of Turku
Effect of Dexmedetomidine Infusion on Gastric Emptying and Gastrointestinal Transit in Healthy Volunteers
The aim of the study is to determine the effect of dexmedetomidine infusion on gastric emptying and oro-caecal transit time in healthy volunteers, judged by measuring plasma paracetamol concentrations after paracetamol ingestion and pulmonary hydrogen measurement technique after lactulose ingestion.
The effects of dexmedetomidine will be compared to the effects of morphine and placebo.
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段1
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
-
-
-
Turku、芬兰、20520
- Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital
-
-
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
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Normal cognitive function and fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel
- Age ≥ 18 years.
- Male gender.
- Weight ≥ 60 kg.
- Written informed consent from the subject.
Exclusion Criteria:
- Previous history of intolerance to the study drugs or related compounds and additives.
- Concomitant drug therapy of any kind except ibuprofen in the 14 days prior to the study days.
- Existing or recent significant disease.
- History of haematological, endocrine, metabolic or gastrointestinal disease.
- History of asthma or any kind of drug allergy.
- Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
- A positive test result for urine toxicology.
- A "yes" answer to any of the questions in a modified Finnish version of the Abuse Questions
- Donation of blood within six weeks prior to and during the study.
- Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
- BMI > 30 kg / m2.
- Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
- Smoking during one month before the start of the study or during the study period.
- Clinically significant abnormal findings in physical examination, ECG or laboratory screening [routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)].
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
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dexmedetomidine
The study subjects will be given a normal loading dose (1 μg/kg in 20 minutes) of dexmedetomidine (dexmedetomidine hydrochloride 100 μg/ml, Precedex® Abbott Laboratories North Chicago, IL 60064, USA) followed by continuous infusion of 0.7 μg/kg/h for 190 min.
The administration of the loading dose will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
|
The study subjects will be given a normal loading dose (1 μg/kg in 20 minutes) of dexmedetomidine (dexmedetomidine hydrochloride 100 μg/ml, Precedex® Abbott Laboratories North Chicago, IL 60064, USA) followed by continuous infusion of 0.7 μg/kg/h for 190 min.
The administration of the loading dose will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
|
|
有源比较器：Morphine
The study subjects will be given 0.10 mg/kg morphine hydrochloride (morphine hydrochloride 2 mg/ml, Morphin® Nycomed Austria GmbH, St. Peter Strasse 25, A-4021, Linz, Austria) in 20 minutes followed by a placebo infusion for 190 min.
The administration of the morphine infusion will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
|
The study subjects will be given 0.10 mg/kg morphine hydrochloride (morphine hydrochloride 2 mg/ml, Morphin® Nycomed Austria GmbH, St. Peter Strasse 25, A-4021, Linz, Austria) in 20 minutes followed by a placebo infusion for 190 min.
The administration of the morphine infusion will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
|
|
安慰剂比较：Placebo
The study subjects will be given a saline infusion.
|
0.9 % NaCl will be infused.
|
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 |
|---|---|---|
|
The effect of dexmedetomidine on gastric emptying and oro-caecal transit time
大体时间：10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min
|
5 ml venous blood samples will be collected immediately prior to administration of paracetamol (baseline) and thereafter at 10, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min into EDTA tubes for determination of paracetamol plasma concentrations.
End-expiratory breath samples will be obtained immediately prior to administration of lactulose (baseline) and thereafter at 15, 30, 45, 60, 75, 90, 105 and 120 min.
|
10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min
|
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。
调查人员
- 首席研究员：Timo Iirola, MD、Turku University, Turku University Hospital
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
2010年3月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2010年6月1日
研究注册日期
首次提交
2010年3月9日
首先提交符合 QC 标准的
2010年3月9日
首次发布 (估计)
2010年3月10日
研究记录更新
最后更新发布 (估计)
2010年6月4日
上次提交的符合 QC 标准的更新
2010年6月3日
最后验证
2010年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.