The Relationship Between Menstrual Cycle Phases and Postoperative Nausea and Vomiting: The Role of Sugammadex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age between 18 and 40 years
- •Regular menstrual cycle
- •Scheduled for ENT (ear, nose, and throat) surgery
- •Classified as ASA physical status I or II
排除标准
- •Irregular menstrual cycle
- •Unknown date of last menstrual period
- •Receiving estrogen and/or progesterone supplementation
- •Pre-menopausal or menopausal status
- •Breastfeeding
- •Classified as ASA physical status III or IV
- •Apfel score ≥ 3
- •History of drug allergy
- •Surgery duration exceeding 3 hours
- •Age <18 or >40 years
研究组 & 干预措施
Group Luteal
Women in the luteal phase of their menstrual cycle undergoing septorhinoplasty.
干预措施: PONV Assessment Questionnaire (Other)
Group Follicular
Women in the follicular phase of their menstrual cycle undergoing septorhinoplasty.
干预措施: PONV Assessment Questionnaire (Other)
Group ovulatory
Women in the ovulatory phase of their menstrual cycle undergoing septorhinoplasty.
干预措施: PONV Assessment Questionnaire (Other)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: 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.
次要结局
- Relationship Between Sugammadex Use and Postoperative Nausea and Vomiting (PONV)(24 hours after surgery)
- Relationship Between Sugammadex Use and Menstrual Cycle Phase(During anesthesia administration in surgery)
研究者
Burçin Alaçam, MD
Anesthesiology Specialist
Sakarya University