Table 1.
Inclusion and exclusion criteria for the PROVAR trial
| Inclusion | Exclusion |
|---|---|
| Patients scheduled for elective open abdominal surgery with expected duration >3 h |
Chronic lung disease, except COPD GOLD stage I and II and untreated bronchial asthma |
| ASA class 2 and 3 |
Body mass index >40 |
| Expected extubation in the OR |
Hypersensitivity or allergy against one of the drugs administered during the study or against drugs with similar chemical structure |
| Informed consent to participate in the study signed by the patient |
Participation of the patient in another clinical trial within the last 4 weeks |
| History of substance abuse or any other mental status possibly affecting informed consent |
|
| Pregnancy or breastfeeding | |
| Women in an age range of possible pregnancy if not: | |
| • Postmenopausal (12 months of amenorrhea or 6 months of amenorrheawith serum FSH >40 lU/ml) | |
| • Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy) | |
| • Regular and correct use of contraceptives with failure rate of <1% per year | |
| • Sexual inactivity | |
| • Vasectomy of sexual partner | |
| Suspected low patient compliance | |
| Contraindication for MRI exams | |
| Mechanical ventilation within the last 30 days |
ASA, American Society of Anesthesiologists; OR, operating room; COPD, chronic obstructive pulmonary disease; GOLD, global initiative for chronic obstructive lung disease; FSH, follicle-stimulating hormone; MRI, magnetic resonance imaging.