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

NCT07539831 | Recruiting

• 1 other identifier: KSH-ANEST-2025-ONSD-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menstrual Cycle; Optic Nerve Sheath Diameter; Postoperative Nausea and Vomiting

Keywords

Optic Nerve Sheath Diameter; Laparoscopic Gynecologic Surgery; Mini-Mental State Examination; Verbal Descriptive Scale; Follicular Phase; Luteal Phase

Outcome Measures

Primary Outcomes (1)

• Optic Nerve Sheath Diameter

  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.

  Before induction of anesthesia, during surgery, and at the end of surgery

Secondary Outcomes (2)

• Postoperative Nausea and Vomiting

  Within 24 hours after surgery

• Postoperative Cognitive Function

  Preoperative period and 24 hours after surgery

Study Arms (2)

Follicular Phase

Women undergoing elective laparoscopic gynecologic surgery during the follicular phase of the menstrual cycle (approximately days 12-14). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed.

Luteal Phase

Women undergoing elective laparoscopic gynecologic surgery during the luteal phase of the menstrual cycle (approximately days 20-25). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 45 years with ASA physical status I-II who are scheduled for elective laparoscopic gynecologic surgery at Konya City Hospital. Participants will be observed according to menstrual cycle phase (follicular or luteal phase).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• MAHMUT TUTAR, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MAHMUT TUTAR, MD

CONTACT

905552723704; masatu42@gmail.com

MAHMUT TUTAR, md

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Reanimation, Konya City Hospital

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): April 5, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)