Menstrual Status, Anesthetic Consumption, and PONV
ConditionMenstrual Cycle
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 3 trial groupsGroup A: Follicular Phase Group
Group B: Luteal Phase Group
Group C: Postmenopausal Group
Trial outcomes
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).
Time frame
From induction of anesthesia to the end of surgerySecondary outcomes
1
Perioperative Hemodynamic Changes
Changes in mean arterial pressure recorded intraoperatively at predefined time intervals.
Time frame
From induction of anesthesia until the end of surgery2
Postoperative Vomiting
Incidence of vomiting episodes recorded during the postoperative period.
Time frame
Within 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov