VitamIn and oXygen Interventions and Cardiovascular Events

• Status: Completed
• Trial end date: 2020-03-24
• Target enrollment: 0
• Participant gender: All

Summary

This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg
• Treatments: Acetylcysteine; Antioxidants; Ascorbic Acid; N-monoacetylcystine

Criteria

Inclusion criteria:

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:

1. - History of coronary artery disease including angina

2. - History of stroke

3. - Undergoing vascular surgery

4. - History of peripheral arterial disease

5. - Any 2 of the following 8 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

Exclusion criteria:

1. Surgery within 30 days prior to operation

2. Arterial oxygen saturation below 90% without oxygen supplementation

3. Inability to give informed consent

4. Drug allergy towards any of the drugs involved in the trial

5. Previous treatment with bleomycin

6. Pregnancy