NCT03715244 · COMPLETED
Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia
This trial compares two types of anesthesia for short elective surgeries: standard general anesthesia versus spinal anesthesia using short-acting local drugs. Researchers are tracking rates of post-surgery delirium and longer-term cognitive changes up to one year out. It is not a drug being tested for a disease — it is a procedural comparison. The phase is unspecified, making it likely an observational or early comparative study rather than a late-stage trial.
Eligibility criteria
Study group 1 and 2 Inclusion Criteria: * Surgical patients at Campus Virchow - Klinikum and Campus Charité Mitte (Charité - Universitätsmedizin Berlin) * Short, elective procedure (\<90 minutes), feasible in spinal anesthesia * American Society of Anesthesiologists (ASA-Score I to III) * Age ≥ 18 years * Informed consent process Exclusion Criteria: * Non-consenting patients * Lack of consent to participate in the study or to store, process and disseminate pseudonymised study data * Allergy or contraindications to local anesthetics * Contraindications to spinal anesthesia * Coagulopathy or therapy with anticoagulants * Higher grade aortic stenosis * Anomaly of the spinal cord * Pre-existing neurological deficit * Pre-existing neurological disease that severely limits the performance of neurocognitive testing * Hearing and / or visual disturbances (such as color blindness) or relevant language barrier severely limiting the performance of neurocognitive testing * Spinal anesthesia with another local anesthetic * Sole peripheral local anesthesia * Participation in another prospective intervention study * Emergency operation * Pregnancy and breast feeding period POCD Control group: Inclusion criteria: * Male and female patients ages 18-100 years, also controls from the POCD registry (EA1/104/16) * Healthy volunteers (ASA I) / ASA II + III patients who are not scheduled for surgery next year * Ability to consent to oral and written information * Patient education and written consent Exclusion criteria: * Operation in the last six months before inclusion in this study * Lack of consent for the pseudonymised disease data to be stored and shared in this clinical trial * Lack of readiness to participate in the follow-up examinations and contact to make an appointment * Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing * Patients with hearing and / or vision disorders or relevant language barriers that limit the performance of neuro-cognitive testing * Simultaneous participation in a prospective clinical intervention study
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-09-14