Postoperative Hyponatremia - Are There Gender Differences?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change between preoperative and postoperative plasma sodium concentration
研究概览
简要总结
The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible cause for postoperative fluid retention and hyponatremia, and investigate gender differences in this response.
详细描述
30 healthy women and 30 healthy men, who are scheduled for surgery of the middle ear or parotic gland are included in the study. Within each gender group, the subjects are randomized to receive perioperative intravenous fluid regimes either based on body weight or lean body mass (LBM). The surgery lasts for at least 3 hours, the intervention period (fluid administration according to protocol) will last 10-12 hours, the study period will be 20-24 hours. Blood samples for analysis of plasma sodium, potassium, glucose and osmolality are collected preoperatively and the following morning together with analysis of urine produced during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical status I-II
- •Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration
排除标准
- •BMI less than 18
- •BMI greater than 33
- •Diabetes mellitus requiring medication
- •Treatment with diuretics
- •ACE-inhibitors
- •Angiotensin II antagonists
- •Cortisone
- •Diseases of the kidney
- •Pregnancy
- •Menopause
- •Endocrine dysfunction influencing menstruation
结局指标
主要结局
Change between preoperative and postoperative plasma sodium concentration
时间窗: 24 hrs
次要结局
未报告次要终点
研究者
Vibeke Moen
Senior Consultant
Karolinska Institutet