Impact of Menstrual Phases and Menopause on Intraoperative Anesthetic Consumption and Postoperative Nausea and Vomiting: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraoperative Anesthetic Agent Consumption
研究概览
简要总结
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.
详细描述
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.
This 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.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Conversion from laparoscopic to open cholecystectomy
- •History of alcohol, drug, or substance abuse
- •Visual or hearing impairment interfering with study assessments
- •Current hormone replacement therapy
- •Use of oral contraceptives
- •Preoperative nausea or vomiting
- •History of severe postoperative nausea and vomiting
- •Neurological or psychiatric disorders affecting assessment reliability
- •Hemodynamic instability during surgery
- •Postoperative admission to intensive care unit
- •Acute cholecystitis at the time of surgery
- •Refusal to participate or inability to provide informed consent
研究组 & 干预措施
Luteal Phase Group
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.
Postmenopausal Group
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.
Follicular Phase Group
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.
结局指标
主要结局
Intraoperative Anesthetic Agent Consumption
时间窗: From induction of anesthesia to the end of surgery
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).
次要结局
- Perioperative Hemodynamic Changes(From induction of anesthesia until the end of surgery)
- Postoperative Vomiting(Within 24 hours after surgery)
研究者
oya Çimen
MD, Specialist in Anesthesiology
Ankara Etlik City Hospital