Sugammadex, menstrual cycle, and postoperative nausea after septorhinoplasty
The Relationship Between Menstrual Cycle Phases and Postoperative Nausea and Vomiting: The Role of Sugammadex
This project will see if menstrual cycle phase and the use of sugammadex affect postoperative nausea and vomiting in women aged 18–40 having septorhinoplasty.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Sakarya University Academic / other |
| Locations | 1 site (Sakarya, Serdivan) |
| Trial ID | NCT07242209 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling women aged 18–40 with regular menstrual cycles who undergo septorhinoplasty under general anesthesia. Investigators will record menstrual phase at the time of surgery, whether sugammadex is used for neuromuscular blockade reversal, and PONV outcomes using perioperative records and a standardized questionnaire. No extra treatments are given beyond routine clinical care; all data are collected prospectively from anesthesia charts and postoperative assessments. The main analysis compares PONV incidence across follicular, ovulatory, and luteal phases, with a secondary analysis examining any additional association with sugammadex use.
Who should consider this trial
Good fit: Women aged 18–40 with regular menstrual cycles, ASA I–II, not pregnant or breastfeeding, not on estrogen/progesterone supplementation, and scheduled for septorhinoplasty are the ideal candidates.
Not a fit: Women outside the 18–40 age range, with irregular cycles, on hormonal therapy, menopausal or pregnant/breastfeeding, with high PONV risk (Apfel score ≥3), or ASA III–IV are unlikely to gain benefit from participating.
Why it matters
Potential benefit: If successful, the findings could help tailor perioperative PONV prevention by taking menstrual phase and sugammadex use into account, improving comfort and recovery for reproductive-age women.
How similar studies have performed: Consensus guidance and limited prior reports suggest menstrual phase may influence PONV and pharmacokinetic studies show sugammadex can lower progesterone, but direct clinical evidence linking menstrual phase and sugammadex to PONV is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sakarya, Serdivan
- Sakarya University-Anesthesiology and Reanimation Department — Sakarya, Serdivan, Turkey (Türkiye) (Recruiting)
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.