Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedure and One-Lung Ventilation(OLV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary outcome will be changes in oxygenation measured by the PaO2 during one lung ventilation
研究概览
简要总结
The purpose of this study is to evaluate the effects of Dexmedetomidine when used during thoracic surgery.
The primary outcome will be changes in oxygenation as measured the PaO2 during one lung ventilation.
详细描述
To collect data on the effects of Dexmedetomidine(DEX)(0.3mcg/kg loading dose followed by an infusion of 0.3mcg/kg/hr)on Hypoxic pulmonary vasoconstriction when administered to patients during surgery with one lung ventilated thoracic procedures. Dexmedetomidine has both vasoconstricting and vasodilatatory effect on peripheral vasculature but its effect on pulmonary vessels is not known. If it is predominantly a vasodilator on pulmonary vessels it can inhibit hypoxic pulmonary vasoconstriction and will increase shunting of venous blood to arterial circulation without oxygenation. If our study proves it to be a vasodilator for pulmonary vessels then it will not be wise to use it in thoracic procedure with one lung ventilation. If our study proves that it is a vasoconstrictor for pulmonary vessels, then it will be an excellent adjunct to other anesthetic agents during one lung ventilation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age.
- •Subject is American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
- •If female, subject is non-lactating and is either:
- •Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- •Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
- •Subject requires thoracic surgical procedure .
- •Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board.
排除标准
- •Subject has received general anesthesia within 7 days prior to study entry, has received any experimental drug within 30 days prior to study drug administration, or has been previously enrolled in this study.
- •Subject has central nervous system (CNS) disease with an anticipated potential for increased intracranial pressure, an uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment.
- •Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure.
- •Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are contraindicated.
- •Subject has received an IV opioid within one hour, or PO/IM opioid within four hours, of the start of study drug administration.
- •Subject has acute unstable angina, acute myocardial infarction documented by laboratory findings in the past six weeks, heart rate < 50 bpm, SBP < 90 mmHg, or third-degree heart block unless patient has a pacemaker.
- •Subject has known elevated SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper limit of normal (ULN) within the two months prior to screening, and/or a history of liver failure.
- •Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
- •On vasodilators, i.e.,nitroglycerin, nitroprusside, or ACE inhibitors
- •on vasopressors, i.e, norepinephrine,epinephrine, or vasopressin
研究组 & 干预措施
Dexmedetomidine
Those requiring thoracic surgery and receiving dex
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The primary outcome will be changes in oxygenation measured by the PaO2 during one lung ventilation
时间窗: During thoracic surgical procedure
次要结局
未报告次要终点