NCT01250418终止不适用
A Comparison Between the Correlation of the Bispectral Index Versus Snap Index With the Observer's Assessment of Alertness and Sedation (OAA/S) Scale During a Sedation Regimen With and Without Ketamine
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- TcCO2 Above 50
研究概览
简要总结
The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine?
The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age : 18-64 years
- •ASA : I-III
- •Procedure : Breast or gynecological surgery
- •Anesthesia :Monitored anesthesia care
排除标准
- •Pregnancy
- •Breast Feeding
- •Body Mass Index >35kg/m2
- •Drug or Alcohol abuse
- •Use anticonvulsants
- •History of CVA
- •Drop-out criteria:
- •Patient or surgeon request
- •Conversion to general anesthesia
- •Inability to obtain data from both monitors
研究组 & 干预措施
Ketamine Group
Active Comparator
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
干预措施: Ketamine group (Drug)
结局指标
主要结局
TcCO2 Above 50
时间窗: Intraoperative, an average of about 1 and 1/2 hours.
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
次要结局
未报告次要终点
研究者
Gildasio De Oliveira
Gildasio De Oliveira, M.D. Principal Investigator
Northwestern University
研究点 (1)
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