A trial of the effectiveness of tablet medication to prevent low blood pressure after surgery
- Conditions
- Postoperative hypotensionSurgery - Other surgery
- Registration Number
- ACTRN12624000342516
- Lead Sponsor
- The Royal Melbourne Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method