ACTRN12624000342516尚未招募3 期
A pilot trial of the effectiveness of midodrine, atomoxetine or placebo to prevent ward hypotension in adults who are hypotensive in the Post Anaesthesia Care Unit after major surgery.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •The study will include patients:
- •aged equal to or greater than 18 years, and
- •who have had major non-cardiac, non-obstetric surgery, under general anaesthesia who are expected to stay at least two postoperative nights in hospital, and
- •who are hypotensive (SBP <90 mmHg) for at least 10 minutes in the PACU or who are administered vasoactive medication in PACU,
- •who are assessed as suitable for discharge to the ward, and
- •who are able to communicate in English, including with the support of an interpreter.
排除标准
- •The study will exclude potential participants where:
- •age is less than 18 years old
- •hypotension was present before surgery
- •there is a clear cause of hypotension not related to vasodilation as assessed by the treating anaesthetist, including:
- •oarrhythmia
- •obleeding requiring intervention
- •oacute reduction in cardiac output
- •oanaphylaxis
- •oother clinical explanation requiring specified treatment
- •the patient is in cardiac arrest,
- •they are receiving intravenous vasopressor infusions and are planned for admission to the intensive care unit,
- •they are unable to safely swallow capsules,
- •there is a surgical necessity to avoid vasopressors
- •oIntracranial neurosurgery
- •oRenal transplant
- •oBowel anastomosis
- •oReconstructive flap surgery (inc. DIEP, limb or head and neck free flap)
- •they are receiving dialysis,
- •they are pregnant or breastfeeding,
- •they are unable to communicate at all in English,
- •There is a known contraindication to a study medication:
- •oHypersensitivity to the active substance or to any of the excipients
- •oHypersensitivity to atomoxetine or any excipients in this product.
- •oSevere organic heart disease (e.g., bradycardia, recent heart attack, congestive heart failure, cardiac conduction disturbances or aortic aneurysm).
- •oHypertension (current and severe – e.g., SBP > 160 mmHg)
- •o Serious obliterative blood vessel disease, cerebrovascular occlusions and vessel spasms.
- •oAcute kidney disease or severe renal impairment (creatinine clearance of less than 30 ml/min).
- •oSerious prostate disorder
- •oUrinary retention
- •oProliferative diabetic retinopathy
- •oPhaeochromocytoma.
- •oHyperthyroidism or thyrotoxicosis.
- •oNarrow angle glaucoma.
- •oUncontrolled hyperthyroidism
- •oUse of Monoamine Oxidase Inhibitors with other drugs that affect brain monoamine concentrations
- •Are previously enrolled in the FAME study
- •Or are prescribed medications that inhibit cytochrome CYP2D6
研究者
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