Sugammadex and Menstrual Cycle in Postoperative Nausea and Vomiting (NCT07242209) | Clinical Trial Compass
CompletedNot Applicable
Sugammadex and Menstrual Cycle in Postoperative Nausea and Vomiting
Turkey (Türkiye)60 participantsStarted 2025-12-18
Plain-language summary
This observational study aims to evaluate the relationship between menstrual cycle phases and the incidence of postoperative nausea and vomiting (PONV) in women of reproductive age undergoing septorhinoplasty surgery. The study's primary objective is to determine whether different phases of the menstrual cycle are associated with variations in PONV frequency. As a secondary objective, the relationship between menstrual phases, PONV incidence, and the use of sugammadex during anesthesia will be analyzed. No additional intervention will be applied beyond routine clinical practice; all data will be collected prospectively from anesthesia records and postoperative evaluations.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female sex
* Age between 18 and 40 years
* Regular menstrual cycle
* Scheduled for ENT (ear, nose, and throat) surgery
* Classified as ASA physical status I or II
Exclusion Criteria:
* Irregular menstrual cycle
* Unknown date of last menstrual period
* Receiving estrogen and/or progesterone supplementation
* Pre-menopausal or menopausal status
* Pregnant
* Breastfeeding
* Classified as ASA physical status III or IV
* Apfel score ≥ 3
* History of drug allergy
* Surgery duration exceeding 3 hours
* Age \<18 or \>40 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether sugammadex and the menstrual cycle affect postoperative nausea and vomiting — if I'm planning surgery, should I be asking about where I am in my cycle when scheduling my procedure, based on what this study found?
2Since this trial has already been completed, can you share or look up what the results showed about whether sugammadex reduced postoperative nausea and vomiting, and whether those findings might change how my anesthesia is managed?
3I know postoperative nausea and vomiting can be influenced by many factors — given that this study specifically focused on the menstrual cycle as a variable, how much does my cycle timing actually matter compared to other standard risk factors my anesthesia team would already consider?
4Since this was a Phase NA study, which sometimes means it's more observational or exploratory, does that affect how confident you are in applying any of its findings directly to decisions about my care?
5Are there already standard protocols your team uses to prevent postoperative nausea and vomiting, and would the findings from this sugammadex and menstrual cycle trial add anything new or change the approach you'd recommend for me specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.