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NCT Number: NCT07539831

Effects of Menstrual Cycle on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery

This observational study aims to evaluate the effect of menstrual cycle phase on optic nerve sheath diameter (ONSD) in women undergoing elective laparoscopic gynecologic surgery. Patients will be grouped according to menstrual cycle phase as follicular or luteal. ONSD measurements will be performed perioperatively, and postoperative nausea and vomiting as well as postoperative cognitive function will also be assessed. The study is designed to investigate whether hormonal variations during the menstrual cycle are associated with differences in intracranial pressure reflected by ONSD measurements and postoperative outcomes

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Key information

Conditions

Menstrual Cycle Nausea Optic Nerve Sheath Diameter Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Konya City Hospital

Konya, Turkey (Türkiye)

Location status: Recruiting

Location contact

MAHMUT TUTAR

CONTACT

MAHMUT TUTAR, MD

CONTACT

[email protected]

905552723704

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Optic Nerve Sheath Diameter

    Time frame: Before induction of anesthesia, during surgery, and at the end of surgery

    The primary outcome is the comparison of optic nerve sheath diameter (ONSD) between women in the follicular phase and those in the luteal phase of the menstrual cycle undergoing elective laparoscopic gynecologic surgery. ONSD will be measured ultrasonographically in the supine position. For each eye, three horizontal and three vertical measurements will be obtained and averaged.

Secondary outcomes

  1. Postoperative Nausea and Vomiting

    Time frame: Within 24 hours after surgery

    Postoperative nausea and vomiting will be assessed using the Verbal Descriptive Scale (VDS) and compared between the follicular-phase and luteal-phase groups. The VDS categories are none, mild, moderate, vomiting once, and severe vomiting.

  2. Postoperative Cognitive Function

    Time frame: Preoperative period and 24 hours after surgery

    Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and compared between the follicular-phase and luteal-phase groups.

Study contacts

Contact information is provided by the study sponsor or research team.

MAHMUT TUTAR, MD

CONTACT

[email protected]

905552723704

MAHMUT TUTAR, md

CONTACT

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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