Genetic Variants and Perioperative Morbidity and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomiting (PONV)
研究概览
简要总结
Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.
详细描述
Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome.
In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery.
Objective
The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants.
Methods
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •Written informed consent
- •Scheduled surgery
排除标准
- •No informed consent
- •Cognitive impairment
研究组 & 干预措施
All patients
Patients undergoing elective surgery with anesthesia
结局指标
主要结局
Postoperative nausea and vomiting (PONV)
时间窗: Up to 48 hours after surgery
Percent of patients with no PONV, medium PONV and severe PONV PONV outcome measured by a composite score: number of episodes of vomiting + severity of nausea (NRS score) + need for antiemetic treatment Patients with no PONV are compared to those with intermediate and severe PONV
次要结局
- Pain related impairment after surgery(up to 2 days after surgery)
- Cardio-vascular events after surgery(Up to 30 days after surgery)
- Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery(up to one year after surgery)
- What influences pain related impairment after bariatric surgery(up to 1 year after surgery)
- Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery(up to one year after surgery)