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NCT Number: NCT07456202

Menstrual Status, Anesthetic Consumption, and PONV

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location status: Recruiting

Location contact

Fethi Gültop, Specialist in Anesthesiology

CONTACT

+905052260067

oya çimen, Specialist

CONTACT

[email protected]

+905334494750

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraoperative Anesthetic Agent Consumption

    Time frame: From induction of anesthesia to the end of surgery

    Total 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 outcomes

  1. Perioperative Hemodynamic Changes

    Time frame: From induction of anesthesia until the end of surgery

    Changes in mean arterial pressure recorded intraoperatively at predefined time intervals.

  2. Postoperative Vomiting

    Time frame: Within 24 hours after surgery

    Incidence of vomiting episodes recorded during the postoperative period.

Study contacts

Contact information is provided by the study sponsor or research team.

Fethi Gültop, Specialist in Anesthesiology

CONTACT

[email protected]

+905052260067

oya Çimen, Specialist in Anesthesiology

CONTACT

[email protected]

+905334494750

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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