Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 8:48 AM
Study NCT ID:
NCT07456202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Menstrual Status, Anesthetic Consumption, and PONV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Anesthetic Agent Consumption', 'timeFrame': 'From induction of anesthesia to the end of surgery', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Perioperative Hemodynamic Changes', 'timeFrame': 'From induction of anesthesia until the end of surgery', 'description': 'Changes in mean arterial pressure recorded intraoperatively at predefined time intervals.'}, {'measure': 'Postoperative Vomiting', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Incidence of vomiting episodes recorded during the postoperative period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthetic Consumption', 'Luteal Phase', 'Follicular Phase', 'Postoperative Nausea and Vomiting'], 'conditions': ['Menstrual Cycle']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'This study includes biologically female patients, as the research objective involves evaluation of menstrual cycle phases and menopausal status based on hormonal measurements.1', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18 to 65 years\n* American Society of Anesthesiologists (ASA) physical status I-II-III\n* Scheduled for elective laparoscopic cholecystectomy under general anesthesia\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Age outside the specified range (younger than 18 or older than 65 years)\n* Male patients\n* American Society of Anesthesiologists (ASA) physical status ≥ IV\n* Severe systemic comorbidities (e.g., significant cardiovascular, hepatic, renal, or pulmonary disease)\n* Conversion from laparoscopic to open cholecystectomy\n* History of alcohol, drug, or substance abuse\n* Visual or hearing impairment interfering with study assessments\n* Current hormone replacement therapy\n* Use of oral contraceptives\n* Preoperative nausea or vomiting\n* History of severe postoperative nausea and vomiting\n* Neurological or psychiatric disorders affecting assessment reliability\n* Hemodynamic instability during surgery\n* Postoperative admission to intensive care unit\n* Acute cholecystitis at the time of surgery\n* Refusal to participate or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07456202', 'briefTitle': 'Menstrual Status, Anesthetic Consumption, and PONV', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Impact of Menstrual Phases and Menopause on Intraoperative Anesthetic Consumption and Postoperative Nausea and Vomiting: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'AEŞH-EK-2026-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Follicular Phase Group', 'description': '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.'}, {'label': 'Luteal Phase Group', 'description': '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.'}, {'label': 'Postmenopausal Group', 'description': '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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'oya Çimen, Specialist in Anesthesiology', 'role': 'CONTACT', 'email': 'oya.cimen@hotmail.com', 'phone': '+905334494750'}, {'name': 'Fethi Gültop, Specialist in Anesthesiology', 'role': 'CONTACT', 'email': 'fethigultop@yahoo.com', 'phone': '+905052260067'}], 'overallOfficials': [{'name': 'oya çimen, Specialist in Anesthesiology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 6 months after publication and available for up to 3 years.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Data will be shared electronically after approval of a formal data request and signing of a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Specialist in Anesthesiology', 'investigatorFullName': 'oya Çimen', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}