Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly Patients Undergoing Hip Surgery: A Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- mean arterial pressure
研究概览
简要总结
The current study aims to determine whether norepinephrine infusion rate (0.07 mcg/kg/min) is non-inferior to the higher dose (0.1 mcg/kg/min) in maintaining intraoperative blood pressure maintaining blood pressure of elderly patients during hip surgery
详细描述
Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg in the mean arterial pressure.
Inferior vena cava collapsibility will be used to assess the patient's intravascular volume status.
After induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization All drug preparations will be done by a research assistant who will be responsible for opening the envelope and group assignment with no further involvement in the study.
Any episode of hypotension (defined as mean arterial pressure (MAP) < 70% of the baseline or MAP<65mmHg) will be managed by 5 mcg norepinephrine.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 9 mg ephedrine. If bradycardia occurred with hypertension (MAP increase 20% over the baseline) and persisted for more than one reading, the vasopressor infusion will be stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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)
- •ASA I-II-III
- •scheduled for hip surgery under spinal anesthesia
排除标准
- •Contraindication of spinal anesthesia
- •history of allergy to any of the study's drugs,
- •Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias)
- •patients with uncontrolled hypertension
研究组 & 干预措施
NE 0.1 mcg
norepinephrine infusion rate of 0.1 mcg/kg/min
干预措施: Norepinephrine (0.1 μg/kg/min) (Drug)
NE 0.07 mcg
norepinephrine infusion rate of 0.07 mcg/kg/min
干预措施: Norepinephrine (0.07 μg/kg/min) (Drug)
结局指标
主要结局
mean arterial pressure
时间窗: 0 min after spinal anesthesia till 46 min after spinal anesthesia
average mean arterial pressure
次要结局
- incidence of hypotension(0 min after spinal anesthesia till 46 min after spinal anesthesia)
- incidence of reactive hypertension(0 min after spinal anesthesia till 46 min after spinal anesthesia)
- incidence of bradycardia(0 min after spinal anesthesia till 46 min after spinal anesthesia)
研究者
Maha Mostafa Ahmad, MD
assistant professor
Kasr El Aini Hospital