The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean ANI Changes 3 Min After Ketamine Bolus
研究概览
简要总结
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
详细描述
Researchers at the University of Washington are doing this study to find out if a commonly used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy under general anesthesia.
The investigators will administer routine anesthesia care including Ketamine, a commonly used anesthetic, during the patients surgery. During the patients surgery, the investigators will monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely non-invasive and collects data from the EKG monitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA status I, II, or III
- •18 years or older
- •Receiving GA with uncomplicated routine intubation
- •Ability to provide informed consent
- •English-speaking
排除标准
- •Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy
- •Patient refusal
- •History of substance abuse
- •Patients taking psychotropic and/or opiate drugs
- •Having a history of psychiatric diseases or psychological problems
结局指标
主要结局
Mean ANI Changes 3 Min After Ketamine Bolus
时间窗: Before vs 3 min after Ketamine adminstration
ANI was measured pre- and post- i.v. ketamine administration
Mean ANI Changes 5 Min After Ketamine Bolus
时间窗: Before vs 5 min after Ketamine adminstration
ANI was measured pre- and post- i.v. ketamine administration
Mean ANI Changes After Skin Incision
时间窗: Before vs after skin incision
ANI was measured pre- and post- skin incision
Mean ANI Changes After Intubation
时间窗: Before vs after intubation
ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation
次要结局
- Mean BIS Changes 3 Min After Ketamine Bolus(Before vs 3 min after Ketamine adminstration)
- Mean BIS Changes After Intubation(Before vs after intubation)
- Mean BIS Changes After Skin Incision(Before vs after skin incision)
- Mean MAP Changes After Skin Incision(Before vs after skin incision)
- Change in Mean Arterial Pressure After Intubation(Before vs after intubation)
- Mean Heart Rate Change After Intubation(Before vs after intubation)
- Mean Heart Rate Change 3 Min After Ketamine Bolus(Before vs 3 min after Ketamine adminstration)
- Mean Heart Rate Change After Skin Incision(Before vs after skin incision)
- Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus(Before vs 3 min after Ketamine adminstration)
研究者
Laurent Bollag
Assistant Professor
University of Washington