I95.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients between the ages of 18 and 90 who are undergoing elective surgery with an indication for epidural anesthesia in the fields of urology, gynecology (excluding obstetrics), orthopedics, trauma surgery, and visceral surgery. Also included are patients undergoing semi-elective surgeries in the above-mentioned fields with an indication for epidural anesthesia and marked urgency (N12, N24, N48-72, corresponding to surgery within the next 12, 24, or 48–72 hours).
Exclusion criteria
Exclusion criteria: Patients for whom epidural anesthesia is contraindicated and who were therefore already identified as ineligible for participation during the prior routine preoperative consultation regarding perioperative anesthetic measures are excluded fromparticipation. Contraindications include, for example, known hypersensitivity to local anesthetics and other components of the solution, hemorrhagic diathesis, use of anticoagulants (in accordance with guidelines), sepsis and local infection at the puncture site, or refusal of the procedure by the patient. • Refusal to participate in the study despite planned epidural anesthesia. • Patients incapable of understanding or giving informed consent, as well as those with acute neurological disorders or acute intoxication with alcohol, painkillers, and sedatives, or antipsychotics (neuroleptics, antidepressants, lithium) are excluded from participation. • Terminally ill patients with a life expectancy of less than 24 hours are also ineligible to participate in the study. • Unplanned epidural anesthesia during pregnancy for childbirth constitutes an exclusion criterion for the study (due to insufficient time for informed consent). • Conditions that could influence the orthostatic response also lead to exclusion from the study. These include: - Severe aortic stenosis - Severe heart failure (LVEF < 30%) - Bradycardic atrial fibrillation - Parkinson’s disease (with known blood pressure involvement) - Multiple system atrophy - Untreated but known hypothyroidism requiring treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of occurrence of orthostatic dysregulation in percent during the placement of a peridural anesthesia in sitting and lying position | — |
Secondary
| Measure | Time frame |
|---|---|
| Subgroup analysis of the occurrence probability of orthostatic dysregulation in percent according to biological sex (male/female) and age (cut-off value 65 years) Frequency of complications during the placement of a PDA in comparison from lying to sitting position o Hypotension o Bradycardia o Dizziness o Cold sweating o Unconsciousness o Resuscitation o Perforation of the dura mater | — |
Countries
Germany
Contacts
Klinikum Fulda