Menstrual Status, Anesthetic Consumption, and PONV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Menstrual Cycle. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Menstrual Phases and Menopause on Intraoperative Anesthetic Consumption and Postoperative Nausea and Vomiting: A Prospective Observational Study
Overview
This prospective observational cohort study aims to evaluate the association between menstrual phase (determined by postoperative serum progesterone levels), intraoperative anesthetic consumption, and the incidence and severity of postoperative nausea and vomiting (PONV) in female patients undergoing cholecystectomy. Intraoperative anesthetic requirements will be recorded, and postoperative nausea and vomiting will be assessed using standardized scoring systems.
Detailed description
Hormonal fluctuations during the menstrual cycle may influence anesthetic requirements and susceptibility to postoperative nausea and vomiting (PONV). However, the relationship between menstrual phase and intraoperative anesthetic consumption remains unclear.
This prospective observational cohort study will include female patients undergoing elective cholecystectomy under general anesthesia. No intervention will be applied beyond standard clinical practice. Intraoperative anesthetic drug consumption will be recorded quantitatively. Postoperative nausea and vomiting will be evaluated during the early postoperative period using validated assessment tools.
Primary outcome measures
- Intraoperative Anesthetic Agent Consumption [Time frame: From induction of anesthesia to the end of surgery]
Secondary outcome measures (2)
- Perioperative Hemodynamic Changes [Time frame: From induction of anesthesia until the end of surgery]
- Postoperative Vomiting [Time frame: Within 24 hours after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Ankara Etlik City Hospital — Ankara
Identifiers
NCT: NCT07456202 · AEŞH-EK-2026-005