Menstrual cycle effects on optic nerve sheath diameter during laparoscopic gynecologic surgery
The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
This study will try to see if menstrual cycle phase changes the optic nerve sheath size and affects postoperative nausea, vomiting, and thinking in women having elective laparoscopic gynecologic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Konya City Hospital Academic / other |
| Locations | 1 site (Konya) |
| Trial ID | NCT07539831 on ClinicalTrials.gov |
What this trial studies
In this single-site observational study at Konya City Hospital, women aged 18–45 scheduled for elective laparoscopic gynecologic surgery will be grouped by menstrual phase (follicular versus luteal). Perioperative optic nerve sheath diameter (ONSD) measurements will be taken and postoperative nausea and vomiting plus cognitive function (using the Mini-Mental State Examination and verbal descriptive scales) will be recorded. Key exclusions include irregular menstrual cycles, pregnancy or breastfeeding, neurological or eye diseases affecting intracranial pressure, prior brain surgery, and uncontrolled severe cardiovascular disease. The study aims to see whether normal hormonal fluctuations across the menstrual cycle are associated with differences in ONSD and short-term postoperative outcomes.
Who should consider this trial
Good fit: Women aged 18–45 with regular menstrual cycles, ASA physical status I–II, scheduled for elective laparoscopic gynecologic surgery during either the follicular or luteal phase.
Not a fit: Patients outside the age range, with irregular cycles (for example PCOS or early menopause), who are pregnant or breastfeeding, or who have neurological/ocular conditions affecting intracranial pressure, prior brain surgery, or uncontrolled severe cardiovascular disease are unlikely to benefit from participation.
Why it matters
Potential benefit: If a link is found, clinicians could tailor perioperative monitoring and care by menstrual phase to potentially reduce postoperative nausea or short-term cognitive changes.
How similar studies have performed: ONSD has been used as a noninvasive marker of intracranial pressure in other settings, but directly testing menstrual cycle effects on ONSD is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 to 45 years * Scheduled for elective laparoscopic gynecologic surgery * Menstrual cycle in the follicular phase or luteal phase * American Society of Anesthesiologists (ASA) physical status I-II Exclusion Criteria: * Irregular menstrual cycle (e.g., polycystic ovary syndrome, early menopause, hypothalamic amenorrhea) * Pregnancy or breastfeeding * Neurological disease associated with intracranial pressure changes * Glaucoma or another eye disease associated with high intraocular pressure * Previous brain surgery * Uncontrolled hypertension or severe cardiovascular disease
Where this trial is running
Konya
- Konya City Hospital — Konya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Mahmut Tutar, Md — Konya City Hospital
- Study coordinator: Mahmut Tutar, Md
- Email: masatu42@gmail.com
- Phone: 905552723704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.