Hyperoxia and antioxidant intervention during major non-cardiac surgery and risk of cerebral and cardiovascular complications, a blinded 2x2 factorial randomized clinical trial

Bispebjerg Hospital0 个研究点目标入组 600 人开始时间: 2017年7月6日最近更新: 2021年6月7日

试验速览

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•All of the listed criteria (1.-4.) must be met.
•1. Age 45 years or above
•2. Elective or acute surgery in general anaesthesia
•3. Scheduled for abdominal, orthopaedic, or vascular surgery with expected surgery duration of one hour or more.
•4. Fulfil any 1 of the following 5 criteria:
•a)- History of coronary artery disease including angina
•b)- History of stroke
•c)- Undergoing vascular surgery
•d)- History of peripheral arterial disease
•e)- Any 2 of the following 7 criteria:
•i.Acute surgery
•ii.Current or previous daily smoking
•iii.History of hypertension
•iv.Diabetes mellitus requiring medical treatment
•v.History of transient cerebral ischemia
•vi.Plasma creatinine >175 µM
•vii.Age 70 years or above
•viii.History of congestive heart failure
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Pregnant women will be excluded. A routine HCG will not be measured, if women are 50 years or older. Preoperative inability to give informed consent, arterial oxygen saturation (SpO2) below 90% without oxygen supplementation before surgery; drug allergy involving any of the interventional drugs; surgery within 30 days of operation; previous use of bleomycin due to the risk of pulmonary fibrosis.

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