Sakarya University-Anesthesiology and Reanimation Department
Sakarya, Serdivan, 54050, Turkey (Türkiye)
NCT Number: NCT07242209
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.
Looking for future studies?
Notify Me18 year–40 year
Female
Observational
Sakarya, Serdivan, 54050, Turkey (Türkiye)
This clinical trial aims to evaluate the effect of menstrual cycle phases on the incidence of postoperative nausea and vomiting (PONV) in women of reproductive age undergoing septorhinoplasty under general anesthesia. PONV is a common postoperative complication that can negatively impact patient recovery, prolong discharge time from the post-anesthesia care unit, and decrease overall patient satisfaction. Several risk factors for PONV have been identified, and recent consensus guidelines published in 2020 have also suggested that the menstrual cycle may influence PONV risk.
In this prospective observentional study, participants will be randomly assigned to receive either preoperative nebulized lidocaine or nebulized 3% sodium chloride solution, administered 15 minutes before surgery. The primary objective is to determine whether menstrual cycle phase (follicular, ovulatory, or luteal) is associated with differences in PONV incidence. The secondary objective is to evaluate whether the use of sugammadex during anesthesia has an additional effect on PONV occurrence across different menstrual phases.
Sugammadex, a modified γ-cyclodextrin that selectively binds aminosteroidal neuromuscular blocking agents such as rocuronium, may also interact with endogenous steroid hormones. Pharmacokinetic studies have shown that sugammadex exposure can decrease progesterone levels by approximately 34% and may reduce estrogen levels as well. Given the hormonal fluctuations during the menstrual cycle, understanding these interactions may help identify specific phases associated with increased PONV risk and support the development of individualized anesthesia management strategies.
All participants will receive standard anesthetic and surgical care. PONV assessment will be performed in the postoperative care unit and during the first 24 hours after surgery. Demographic data, anesthetic drug information, menstrual cycle phase, and PONV outcomes will be recorded and statistically analyzed.
The results of this trial may contribute to improved understanding of the interaction between hormonal status, anesthetic drugs, and postoperative outcomes, potentially informing future preventive measures for PONV in women undergoing elective surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All 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.
Time frame: Within 24 hours after surgery
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: 24 hours after surgery
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: During anesthesia administration in surgery
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.
Sakarya University
Other
The Relationship Between Menstrual Cycle Phases and Postoperative Nausea and Vomiting: The Role of Sugammadex
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07539831
Menstrual Cycle, Nausea
Konya, Turkey (Türkiye)
View Trial DetailsNCT06546514
Anxiety Disorders, Mental Disorders
Erzurum, Palandöken, Turkey (Türkiye)
View Trial DetailsNCT05676294
Nausea, Pathologic Processes
New Haven, Connecticut, United States
View Trial DetailsNCT07688811
Anesthesia Complication, Nausea
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
View Trial Details