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临床试验/NCT03719001
NCT03719001已完成早期 1 期

A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年10月23日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg

干预措施: Phenylephrine (Drug)

Dexmedetomidine

Experimental

Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg

干预措施: Dexmedetomidine (Drug)

Clevidipine

Experimental

Clevidipine infusion will be used to increase blood pressure by 20 mmHg

干预措施: Clevidipine (Drug)

Calcium Chloride

Experimental

Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration

干预措施: Calcium Chloride (Drug)

tetanic stimulus

Experimental

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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