Correlation Between Postprandial Hypotension and Perioperative Adverse Events Such as Post-induction Hypotension in the Elderly: a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Post-induction hypotension
研究概览
简要总结
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.
详细描述
With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients (≥ 65 years old）;
- •Patients with American Society of Anesthesiologists(ASA) grade I-III;
- •Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
- •Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；
排除标准
- •Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
- •Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
- •Patients with chronic kidney disease requiring dietary restrictions or dialysis.
- •Patients with Parkinson's disease or other conditions causing tremors.
- •Patients with problems related to oral food ingestion or those requiring enteral nutrition.
- •Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures.
- •Patients unable to remain in a supine position for at least 2 hours.
结局指标
主要结局
Post-induction hypotension
时间窗: Within 20 minutes after induction or before incision.
which is defined as systolic blood pressure (SBP) \<90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)\<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision.
次要结局
- Postoperative complications(Within 30 days after surgery)
- early intraoperative hypotension （eIOH）(within the first 30 minutes after the start of surgery)
- mortality within 30 days after surgery(within 30 days after surgery)
- 12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)(within 180 days after surgery)