A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- myogenic oscillations
研究概览
简要总结
Spontaneous myogenic oscillations will be studied under general anesthesia using finger photoplethysmography. This pilot study will explore potential physiological conditions that will effect the amplitude and/or frequency of myogenic oscillations.
详细描述
This is a single center, nonrandomized, nonblinded, interventional clinical pilot research study that plans to enroll 40 patients.
Study will be conducted while subjects are under general anesthesia.
Myogenic oscillations will be measured using finger photoplethysmography. Changes in the amplitude and/or frequency of these oscillations will be analyzed in response to the interventions. Arterial blood pressure will be recorded to verify the efficacy of the interventions.
Six different interventions that will either lower or increase blood pressure will be applied to the subjects. Each subject will receive 1 or 2 of the six interventions. Each of the 6 interventions will be applied to 8 subject.
The interventions that the subject will not be randomized. They will be determined by the subjects blood pressure immediately before the intervention to guarantee that the blood pressure manipulations are within a safe range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 yrs of age
- •Undergoing surgery in Moffitt-Long operating rooms
- •Receiving general anesthesia
- •Will have an intra-arterial catheter for clinical purposes
- •Able to consent in english
排除标准
- •Under 18 years of age
- •unable to provide informed consent
研究组 & 干预措施
Phenylephrine
Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg
干预措施: Phenylephrine (Drug)
Dexmedetomidine
Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg
干预措施: Dexmedetomidine (Drug)
Clevidipine
Clevidipine infusion will be used to increase blood pressure by 20 mmHg
干预措施: Clevidipine (Drug)
Calcium Chloride
Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration
干预措施: Calcium Chloride (Drug)
tetanic stimulus
A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone
干预措施: tetanic stimulus (Other)
Increased venous pressure
A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm.
干预措施: Increased venous pressure (Other)
结局指标
主要结局
myogenic oscillations
时间窗: up to 5 minutes
change in amplitude and/of frequency of myogenic oscillations
次要结局
未报告次要终点
