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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07360756
Eligibility Criteria:
Inclusion Criteria:
* Adult female patients, aged 18-45 years
* ASA(American Society of Anesthesiologists) physical status II or III
* Scheduled for elective cesarean section
* Undergoing surgery under standardized spinal anesthesia
Exclusion Criteria:
* Pre-existing headache disorders (e.g., migraine, chronic tension-type headache)
* Known ophthalmic conditions (e.g., optic neuropathy, glaucoma)
* Inability to cooperate with ONSD(Optic Nerve Sheath Diameter) ultrasound measurements or follow-up
* Allergy to local anesthetics
* Emergency cesarean section
* Contraindications to spinal anesthesia:
* Coagulopathy
* Infection at the puncture site
* Preexisting hypertension on medication
* Pre-eclampsia with severe features (suggested for separate study)
* Known cardiac disease with hemodynamic instability
* Allergy to study drugs
* Fetal distress or non-reassuring cardiotocography (CTG)
* Body Mass Index (BMI) \>40 kg/m²
* Refusal to sign informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07360756
Study Brief:
Protocol Section:
NCT07360756