CYP3A, perioperative inflammation
Conditions
Interventions
Group 1: assessment of the influence of perioperative inflammation of elective operations on CYP3A-activity (midazolam phenotyping): CYP phenotyping: 0 h , 48 h, 7 d. characterisation of immune syste
Sponsors
Universtitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Patients with major elective visceral surgery requiring general, neuraxial or regional anaesthesia, -Patients with an American Society of Anesthesiologists (ASA) classification of 1-3 at the time of the examination, -Capable of giving written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonisation (ICH) guideline E6 on Good Clinical Practice (GCP) and applicable regulations prior to any procedures associated with the study.
Exclusion criteria
Exclusion criteria: 1. emergency operations, 2. planned liver resection or transplantation, 3. acute hepatitis, 4. ASA 4 and 5 at the time of the examination, 5. any autoimmune disease (including type I diabetes), 6. dialysis-dependent renal failure, 7. pregnancy or breastfeeding, or 8. respiratory insufficiency and depression; or 9. any known history of severe allergic or anaphylactic reaction to midazolam 10. regular use of known strong CYP3A inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort), 11. regular intake of known strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, erythromycin, ritonavir, grapefruit juice) 12. blood haemoglobin values < 10 g/d, or 13. general refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • perioperative CYP3A-activity by midazolam phenotyping o at the beginning of the surgical operation, o 48 h post-OP and o day 7 post-OP/ prior to discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| erioperative immune status (quantification of plasmazytokines, measurmente ex-vivo-cytokine production capactity, analysis of immune cell distribution) o at the beginning of the surgical operation, o 4 h post-OP, o 24 h post-OP, o 48 h post-OP und o day 7 post-OP/ prior to discharge. | — |
Countries
Germany
Contacts
Public ContactLars Werntz
Universitätsklinikum Heidelberg
Outcome results
None listed