Menstrual CycleNCT07456202
Menstrual Status, Anesthetic Consumption, and PONV
An observational study of Menstrual Cycle, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Menstrual Cycle
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2026to 16 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Ankara, 06170
oya çimen, Specialist, +905334494750, oya123cimen@gmail.com
Fethi Gültop, Specialist in Anesthesiology, +905052260067
About this study
Official title: 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.
Read the 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.
- Conditions
- Menstrual Cycle
- Keywords
- Anesthetic Consumption, Luteal Phase, Follicular Phase, Postoperative Nausea and Vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From induction of anesthesia to the end of surgery
Secondary outcomes (2)
Perioperative Hemodynamic Changes
Changes in mean arterial pressure recorded intraoperatively at predefined time intervals.
Measured: From induction of anesthesia until the end of surgery
Postoperative Vomiting
Incidence of vomiting episodes recorded during the postoperative period.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start7 Mar 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion16 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, oya Çimen, Ankara Etlik City Hospital
- Investigators
- oya çimen, Specialist in Anesthesiology, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456202
- Sponsor's protocol ID
- AEŞH-EK-2026-005
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Menstrual Phases and Menopause on Intraoperative Anesthetic Consumption and Postoperative Nausea and Vomiting: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07456202
- Acronym / sponsor ID
- AEŞH-EK-2026-005
- Conditions
- Menstrual Cycle
- Keywords
- Anesthetic Consumption, Luteal Phase, Follicular Phase, Postoperative Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 16 Aug 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Perioperative Hemodynamic Changes
Time frame: From induction of anesthesia until the end of surgery
Postoperative Vomiting
Time frame: Within 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
oya çimen, Specialist in Anesthesiology principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact oya Çimen, Specialist in Anesthesiology (+905334494750, oya.cimen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Anesthetic Agent Consumption (time frame: From induction of anesthesia to the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.