Background
Methods
Study design and patients
Randomization and blinding
Medication, anaesthesia, and monitoring
Blood samples
Data collection
Endpoints
Sample size
Statistical analysis
Results
Characteristics of the patients
TMZ (n = 40) | Placebo (n = 40) | P | |
---|---|---|---|
Age, years | 65 ± 6 | 64 ± 8 | 0.86 |
Men, n (%) | 28 (70.0) | 26 (65.0) | 0.92 |
BMI (Kg/m2) | 26.3 ± 3.2 | 26.2 ± 3.3 | 0.74 |
NYHA classification, n (%) | |||
I | 12 (30.0) | 13 (32.5) | 0.85 |
II | 18 (45.0) | 19 (47.5) | 0.95 |
III | 7 (17.5) | 6 (15.0) | 0.64 |
IV | 3 (7.5) | 2 (5.0) | 0.35 |
ASA classification, n (%) | |||
II | 6 (15.0) | 7 (17.5) | 0.64 |
III | 30 (75.0) | 28 (70.0) | 0.76 |
IV | 4 (10.0) | 5 (12.5) | 0.85 |
History of smoking, n (%) | 12 (30) | 10 (25) | 0.72 |
History of dyslipidemia, n (%) | 25 (62.5) | 21 (52.5) | 0.58 |
History of hypertension, n (%) | 11 (27.5) | 13 (32.5) | 0.80 |
History of CAD, n (%) | 31 (77.5) | 32 (80.0) | 0.86 |
History of percutaneous intervention or CABG for CAD, n (%) | 8 (20) | 9 (22.5) | 0.79 |
History of stroke, n (%) | 5 (12.5) | 4 (10.0) | 0.85 |
History of diabetes mellitus, n (%) | 10 (25.0) | 9 (22.5) | 0.75 |
Medication history, n (%) | |||
ß-blockers | 29 (72.5) | 31 (77.5) | 0.76 |
ACEI/ARB | 30 (75.0) | 32 (80.0) | 0.82 |
Statins | 26 (65.0) | 27 (67.5) | 0.89 |
Insulin | 4 (10.0) | 3 (7.5) | 0.85 |
Oral anti-diabetic drugs only | 10 (25.0) | 11 (27.5) | 0.88 |
Antiplatelet agents | 16 (40) | 14 (35) | 0.74 |
Type of surgery, n (%) | |||
Major general | 11 (27.5) | 15 (37.5) | 0.56 |
Major orthopedic | 21 (52.5) | 19 (47.5) | 0.64 |
Major vascular | 8 (20.0) | 6 (15.0) | 0.80 |
Preoperative troponin elevation, n (%) | 2 (5.0) | 3 (7.5) | 0.45 |
Operation duration (min) | 156 ± 24 | 162 ± 28 | 0.79 |
Blood loss (ml) | 256 ± 146 | 267 ± 165 | 0.62 |
BIS values | 45 ± 12 | 46 ± 14 | 0.83 |
Occurrence of in-hospital cardiovascular events
Perioperative events
TMZ (n = 40) | Placebo (n = 40) | P | |
---|---|---|---|
Delirium, n (%) | 4 (10.0) | 5 (12.5) | 0.15 |
Incidence of postoperative nausea and vomiting, n (%) | 5 (12.5) | 6 (15.0) | 0.45 |
ICU stay, hours, Mean (SD) | 10 (2) | 14 (1) | 0.04 |
In-hospital morbidity and mortality, n (%) | 2 (5.0) | 1 (2.0) | < 0.05 |
Length of hospital stay, days, Mean (SD) | 7 (1) | 9 (1) | 0.20 |
Patient outcomes over 30 days
TMZ (n = 40) | Placebo (n = 40) | P | |
---|---|---|---|
Death, n (%) | 3 (7.5) | 4 (10.0) | 0.10 |
NYHA, n (%) | |||
I | 13 (32.5) | 14 (35.0) | 0.65 |
II | 19 (47.5) | 18 (45.0) | 0.55 |
III | 6 (15.0) | 5 (12.5) | 0.45 |
IV | 2 (5.0) | 3 (7.5) | 0.10 |
AMI, n (%) | 0 | 0 | – |
Arrhythmias requiring treatment, n (%) | 6 (15.0) | 10 (25.0) | 0.02 |
Cardiac dysfunction, n (%) | 2 (5.0) | 2 (5.0) | 0.99 |
Readmission, n (%) | 8 (20.0) | 10 (25.0) | 0.45 |