Effects of Menstrual Cycle on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorKonya City Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
110 Participants
are grouped into 2 trial groupsGroup A: Follicular Phase
Group B: Luteal Phase
Trial outcomes
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.
Time frame
Before induction of anesthesia, during surgery, and at the end of surgerySecondary outcomes
1
Postoperative Nausea and Vomiting
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.
Time frame
Within 24 hours after surgery2
Postoperative Cognitive Function
Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and compared between the follicular-phase and luteal-phase groups.
Time frame
Preoperative period and 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov