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Menstrual Status, Anesthetic Consumption, and PONV

Impact of Menstrual Phases and Menopause on Intraoperative Anesthetic Consumption and Postoperative Nausea and Vomiting: A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07456202
Enrollment
120
Registered
2026-03-06
Start date
2026-03-07
Completion date
2026-08-16
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Cycle

Keywords

Anesthetic Consumption, Luteal Phase, Follicular Phase, Postoperative Nausea and Vomiting

Brief summary

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.

Interventions

None listed

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative Anesthetic Agent ConsumptionFrom induction of anesthesia to the end of surgeryTotal amount of anesthetic agents administered during surgery, recorded quantitatively (e.g., mg of intravenous agents and/or minimum alveolar concentration-hours of volatile anesthetics).

Secondary

MeasureTime frameDescription
Perioperative Hemodynamic ChangesFrom induction of anesthesia until the end of surgeryChanges in mean arterial pressure recorded intraoperatively at predefined time intervals.
Postoperative VomitingWithin 24 hours after surgeryIncidence of vomiting episodes recorded during the postoperative period.

Countries

Turkey (Türkiye)

Contacts

CONTACToya Çimen, Specialist in Anesthesiology
oya.cimen@hotmail.com+905334494750
CONTACTFethi Gültop, Specialist in Anesthesiology
fethigultop@yahoo.com+905052260067
PRINCIPAL_INVESTIGATORoya çimen, Specialist in Anesthesiology

Ankara Etlik City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026