Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT07100158
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years
* ASA physical status I or II
* Scheduled for total knee arthroplasty under spinal anesthesia
* Successful spinal anesthesia with a single attempt using a 27G Quincke spinal needle
* Provided informed consent to participate in the study
Exclusion Criteria:
* History of neurological or central nervous system disorders (e.g., cerebrovascular disease, intracranial hemorrhage, brain tumor)
* Ophthalmological disorders
* Hypertension
* Hepatic encephalopathy
* Renal failure
* Pregnancy
* History of chronic headaches or migraine
* Obesity (BMI \> 35 kg/m²)
* Alcohol or substance abuse
* Psychiatric disorders
* Local infection at the injection site
* Allergy to local anesthetics
* Bleeding diathesis
* Requirement for sedation during the procedure
* Inability to cooperate postoperatively (e.g., mental retardation, language deficits)
* Inability to obtain reliable ONSD measurements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07100158
Study Brief:
Protocol Section:
NCT07100158