A Study to Examine Levels of Sedation During Outpatient Colonoscopies
A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies
研究概览
地位
条件
详细说明
Propofol for sedation during outpatient endoscopy has become a popular technique in place of midazolam and opioid sedation. It has been associated with improved patient satisfaction and a faster recovery with less nausea and vomiting. However, there are a number of potential adverse effects associated with propofol. It has no analgesic effects; therefore, when used for moderate sedation procedures it frequently has to provide deeper levels of sedation to allow a painful procedure to be performed.
Some patients are sedated to the level of general anesthesia and may develop respiratory depression or airway obstruction requiring immediate airway support.
We examined the level of sedation required for patients to comfortably undergo routine colonoscopy using propofol and what monitoring system would best predict the patients who might need an airway intervention.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Texas
-
Dallas、Texas、美国、75246
- Baylor University Medical Center - Department of Anesthesiology
-
-
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
研究人群
描述
Inclusion Criteria:
- Greater than 18 years of age
- ASA classification of I, II, or III
Exclusion Criteria:
- Anesthesiologist plans to use a combination of medications other than propofol for sedation.
- ASA classification IV or higher
- Lesions on forehead or earlobes
学习计划
研究是如何设计的?
队列和干预
团体/队列 |
|---|
|
Blinded Group
SEDline output is unknown to anesthesiologist.
|
|
Unblinded Group
SEDline output is known to anesthesiologist.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Examine possible relationships (correlations) between sedation using the SEDLine monitors and level of sedation using the Ramsay Sedation Scale and examine the number and type of airway interventions and clinical signs performed during the procedure.
大体时间:2 years
|
2 years
|
合作者和调查者
调查人员
- 首席研究员:Michael Ramsay, MD、Baylor Research Institute
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 006-005
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.