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

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.

Study Overview

• Status: Recruiting
• Conditions: Menstrual Cycle

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: oya Çimen, Specialist in Anesthesiology; Phone Number: +905334494750; Email: oya.cimen@hotmail.com
• Study Contact Backup: Name: Fethi Gültop, Specialist in Anesthesiology; Phone Number: +905052260067; Email: fethigultop@yahoo.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06170
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: oya çimen, Specialist; Phone Number: +905334494750; Email: oya123cimen@gmail.com
      • Contact: Fethi Gültop, Specialist in Anesthesiology; Phone Number: +905052260067

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II-III who are scheduled for elective laparoscopic cholecystectomy under general anesthesia. Participants will be classified according to hormonal status (follicular phase, luteal phase, or postmenopausal) based on postoperative serum progesterone levels. All patients will receive standard perioperative care, and no experimental intervention will be applied.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Follicular Phase Group; Female patients undergoing cholecystectomy under general anesthesia who are classified as being in the follicular phase of the menstrual cycle based on postoperative serum progesterone levels. No experimental intervention will be applied. Intraoperative anesthetic consumption and postoperative nausea and vomiting will be recorded as part of routine perioperative management.
Luteal Phase Group; Female patients undergoing cholecystectomy under general anesthesia who are classified as being in the luteal phase of the menstrual cycle according to postoperative serum progesterone levels. No intervention beyond standard clinical care will be performed. Anesthetic drug consumption and postoperative nausea and vomiting outcomes will be documented.
Postmenopausal Group; Female patients undergoing cholecystectomy under general anesthesia who are postmenopausal. These patients will receive standard perioperative care. Intraoperative anesthetic requirements and postoperative nausea and vomiting will be assessed and compared with other hormonal status groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Anesthetic Agent Consumption	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).	From induction of anesthesia to the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Hemodynamic Changes	Changes in mean arterial pressure recorded intraoperatively at predefined time intervals.	From induction of anesthesia until the end of surgery
Postoperative Vomiting	Incidence of vomiting episodes recorded during the postoperative period.	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Principal Investigator: oya çimen, Specialist in Anesthesiology, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2026
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: February 28, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Luteal Phase; Anesthetic Consumption; Follicular Phase
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: AEŞH-EK-2026-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be available upon reasonable request to the corresponding investigator, following publication of the study results, and subject to institutional and ethical approval.
• IPD Sharing Time Frame: Beginning 6 months after publication and available for up to 3 years.
• IPD Sharing Access Criteria: Data will be shared electronically after approval of a formal data request and signing of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No