Sugammadex and Menstrual Cycle in Postoperative Nausea and Vomiting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorSakarya University
About this trial
This observational study aims to evaluate the relationship between menstrual cycle phases and the incidence of postoperative nausea and vomiting (PONV) in women of reproductive age undergoing septorhinoplasty surgery. The study's primary objective is to determine whether different phases of the menstrual cycle are associated with variations in PONV frequency. As a secondary objective, the relationship between menstrual phases, PONV incidence, and the use of sugammadex during anesthesia will be analyzed. No additional intervention will be applied beyond routine clinical practice; all data will be collected prospectively from anesthesia records and postoperative evaluations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female sex
Age between 18 and 40 years
Regular menstrual cycle
Scheduled for ENT (ear, nose, and throat) surgery
Disqualifiers
Irregular menstrual cycle
Unknown date of last menstrual period
Receiving estrogen and/or progesterone supplementation
Pre-menopausal or menopausal status
Trial population
The study population consists of women of reproductive age (18-40 years) who are scheduled to undergo septorhinoplasty surgery under general anesthesia. Eligible participants have a regular menstrual cycle and are classified as ASA physical status I or II. Participants with irregular menstrual cycles, unknown last menstrual period, pre-menopausal or menopausal status, or those receiving hormonal supplementation are excluded. Other exclusion criteria include pregnancy, breastfeeding, ASA III-IV status, high risk for postoperative nausea and vomiting (Apfel score ≥3), history of drug allergy, and surgery duration exceeding 3 hours. Data will be collected prospectively from anesthesia records, postoperative assessments, and standardized questionnaires evaluating postoperative nausea and vomiting (PONV).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PONV Assessment Questionnaire
Other interventionAll participants will complete a standardized postoperative questionnaire designed to assess the presence, frequency, and severity of nausea and vomiting within the first 24 hours after septorhinoplasty surgery. The questionnaire will be administered in the post-anesthesia care unit and during the postoperative follow-up period. Responses will be recorded by trained research staff or anesthesia team members. No experimental drug or additional therapeutic intervention will be applied. The collected data will be used to evaluate possible associations between postoperative nausea and vomiting (PONV) incidence and the menstrual cycle phase (follicular, ovulatory, or luteal). In addition, anesthetic records will be reviewed to document the use of routinely administered perioperative agents, including sugammadex, to assess their potential influence on PONV outcomes.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group Follicular1 intervention
Group B: Group ovulatory1 intervention
Group C: Group Luteal1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative nausea and vomiting
The primary outcome of this study is the incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after septorhinoplasty surgery. PONV will be evaluated using a standardized questionnaire administered during the postoperative recovery period and at 24 hours post-surgery. The presence, frequency, and severity of nausea and vomiting will be recorded. Data will be analyzed according to the menstrual cycle phase (follicular, ovulatory, luteal) to determine possible associations between menstrual phase and PONV occurrence.
Time frame
Within 24 hours after surgerySecondary outcomes
1
Relationship Between Sugammadex Use and Postoperative Nausea and Vomiting (PONV)
This outcome evaluates whether the use of sugammadex during anesthesia is associated with the incidence of postoperative nausea and vomiting (PONV) in women undergoing septorhinoplasty. Anesthetic records will be reviewed to determine sugammadex administration and dosage. PONV incidence within the first 24 hours postoperatively will be compared between patients who received sugammadex and those who did not.
Time frame
24 hours after surgery2
Relationship Between Sugammadex Use and Menstrual Cycle Phase
This outcome evaluates whether sugammadex administration during anesthesia is associated with the menstrual cycle phase in women undergoing septorhinoplasty. Anesthetic records will be reviewed to determine sugammadex use, and menstrual cycle phase (follicular, ovulatory, luteal) will be recorded. The analysis aims to explore potential interactions between sugammadex exposure and hormonal variations across the menstrual cycle.
Time frame
During anesthesia administration in surgerySponsors and contacts
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Source ClinicalTrials.gov