Menstrual phase, anesthetic use, and postoperative nausea after gallbladder removal
Impact of Menstrual Phases and Menopause on Intraoperative Anesthetic Consumption and Postoperative Nausea and Vomiting: A Prospective Observational Study
We will see if menstrual phase affects how much anesthetic women need and their chance of nausea and vomiting after elective laparoscopic gallbladder removal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara, Ankara) |
| Trial ID | NCT07456202 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of women undergoing elective laparoscopic cholecystectomy under general anesthesia. Postoperative serum progesterone will be used to determine menstrual phase, intraoperative anesthetic drug consumption will be recorded quantitatively, and early postoperative nausea and vomiting will be measured with validated scoring tools. No interventions beyond standard clinical care will be applied. The study compares anesthetic requirements and PONV incidence and severity across menstrual phases.
Who should consider this trial
Good fit: Adult women aged 18–65 with ASA physical status I–III scheduled for elective laparoscopic cholecystectomy who are not using hormonal contraception or replacement and can provide informed consent.
Not a fit: Men, people outside the 18–65 age range, those on hormonal therapies, with emergency or converted/open cholecystectomy, or with ASA ≥IV or severe comorbidities are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If a relationship is identified, anesthesia dosing and anti-nausea strategies could be better tailored to menstrual phase to reduce anesthetic exposure or PONV.
How similar studies have performed: Prior small observational studies have reported mixed results, with some suggesting menstrual phase can alter anesthetic sensitivity and PONV risk but evidence remains limited and inconsistent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 to 65 years * American Society of Anesthesiologists (ASA) physical status I-II-III * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * Willing and able to provide written informed consent Exclusion Criteria: * Age outside the specified range (younger than 18 or older than 65 years) * Male patients * American Society of Anesthesiologists (ASA) physical status ≥ IV * Severe systemic comorbidities (e.g., significant cardiovascular, hepatic, renal, or pulmonary disease) * Conversion from laparoscopic to open cholecystectomy * History of alcohol, drug, or substance abuse * Visual or hearing impairment interfering with study assessments * Current hormone replacement therapy * Use of oral contraceptives * Preoperative nausea or vomiting * History of severe postoperative nausea and vomiting * Neurological or psychiatric disorders affecting assessment reliability * Hemodynamic instability during surgery * Postoperative admission to intensive care unit * Acute cholecystitis at the time of surgery * Refusal to participate or inability to provide informed consent
Where this trial is running
Ankara, Ankara
- Ankara Etlik City Hospital — Ankara, Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: oya çimen, Specialist in Anesthesiology — Ankara Etlik City Hospital
- Study coordinator: oya Çimen, Specialist in Anesthesiology
- Email: oya.cimen@hotmail.com
- Phone: +905334494750
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.