Incidence of Orthostatic Intolerance and Orthostatic Hypotension After Administration of Intravenous Morphine in Patients Prior to Hip or Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of orthostatic hypotension
研究概览
简要总结
Incidence of orthostatic intolerance and orthostatic hypotension after intravenous administration of morphine in patients prior to hip or knee arthroplasty.
详细描述
Early postoperative mobilization is crucial for recovery of patients undergoing surgery in the multimodal fast-track approach to perioperative care, since physical immobilization is highly associated with increased risk of postoperative complications and prolonged hospital length of stay. Postoperative mobilization is often delayed due to patients experiencing orthostatic hypotension (OH), defined as a drop in systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg, or orthostatic intolerance (OI), characterized by dizziness, blurred vision, nausea, vomiting, sensation of heat or syncope.
Previous studies have found a high incidence of postoperative OI (> 40 %) among patients undergoing total hip arthroplasty.
A possible causative factor to the high occurrence of OH and OI after surgery could be postoperative pain management by administration of morphine. Morphine is known to have many side-effects including nausea, vomiting, dizziness and orthostatic hypotension.
The object of this study is to isolate and estimate the effect of intravenous morphine on the incidence of OH and OI.
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
- 否
入选标准
- •Patients undergoing primary unilateral total hip arthroplasty (THA), total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA)
- •Patients > 18
- •Patients that understand and speak Danish
- •Patients that have provided written informed consent
排除标准
- •Alcohol or substance abuse
- •Habitual use of opioids
- •Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
- •History of previous orthostatic intolerance or hypotension
- •Cognitive dysfunction
- •Glomerular filtration rate (GFR) < 30 ml/min
- •Cardiac arrhythmia
研究组 & 干预措施
Patients undergoing primary hip or knee arthroplasty
Patients undergoing primary hip or knee arthroplasty
干预措施: Morphine (Drug)
结局指标
主要结局
Incidence of orthostatic hypotension
时间窗: 30 minutes after morphine administration
Orthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization
次要结局
- Changes in cardiac output (CO) during mobilization(Before and 30 minutes after morphine administration)
- Changes in mean arterial pressure (MAP) during mobilization(Before and 30 minutes after morphine administration)
- Changes in systemic vascular resistance (SVR) during mobilization(Before and 30 minutes after morphine administration)
- Changes in cerebral perfusion (ScO2) during mobilization(Before and 30 minutes after morphine administration)
- Changes in heart rate variability (HRV) during Valsalva manoeuvre(Before and 30 minutes after morphine administration)
- Changes in systolic arterial pressure (SAP) during mobilization(Before and 30 minutes after morphine administration)
- Changes in peripheral perfusion index (PPI) during mobilization(Before and 30 minutes after morphine administration)
- Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre(Before and 30 minutes after morphine administration)
- Changes in heart rate (HR) during mobilization(Before and 30 minutes after morphine administration)
- Changes in diastolic arterial pressure (DAP) during mobilization(Before and 30 minutes after morphine administration)
- Changes in stroke volume (SV) during mobilization(Before and 30 minutes after morphine administration)
- Changes in muscular perfusion (SmO2) during mobilization(Before and 30 minutes after morphine administration)
研究者
Bodil Uldall-Hansen
Research assistant
Copenhagen University Hospital, Hvidovre