Menstrual Status, Anesthetic Consumption, and PONV

NCT07456202 | Recruiting

• 1 other identifier: AEŞH-EK-2026-005
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Cycle

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Perioperative Hemodynamic Changes

  From induction of anesthesia until the end of surgery

• Postoperative Vomiting

  Within 24 hours after surgery

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study includes biologically female patients, as the research objective involves evaluation of menstrual cycle phases and menopausal status based on hormonal measurements.1
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• oya çimen, Specialist in Anesthesiology

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

oya Çimen, Specialist in Anesthesiology

CONTACT

+905334494750; oya.cimen@hotmail.com

Fethi Gültop, Specialist in Anesthesiology

CONTACT

+905052260067; fethigultop@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist in Anesthesiology

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 6, 2026
• Study Start: March 7, 2026
• Primary Completion: May 27, 2026
• Study Completion: June 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication and available for up to 3 years.
• Access Criteria: Data will be shared electronically after approval of a formal data request and signing of a data use agreement.

Locations

TU (1)