Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension in High-risk Patients Undergoing Major Abdominal Surgery: a Randomized Double-blinded Controlled Trial: a Randomized Double-blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- incidence of postinduction hypotension
研究概览
简要总结
The aim of this work is to assess the efficacy of intermittent ephedrine boluses in prophylaxis against postinduction hypotension in high-risk patients undergoing major abdominal surgery, compared to standard care.
详细描述
Fluid responders (≥20% rise in perfusion index on passive leg raising) will receive 500-mL Ringer's boluses (up to 1500 mL). Anesthesia will be induced with fentanyl/propofol, intubated after neuromuscular blockade, and maintained with isoflurane (1.2% end-tidal). Study drug will be given at induction and every 5 minutes for 20 minutes, withheld if MAP ≥80 mmHg or a recent vasopressor dose. Hypotension (MAP <65 mmHg) will be treated with 0.1 mg/kg ephedrine boluses (max 9 mg single). Post-incision care follows anesthetist discretion.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged >50 years,
- •weight >50 kg,
- •American Society of Anesthesiologists (ASA) Physical Status score of > I,
- •undergoing major abdominal surgery
排除标准
- •Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, significant uncontrolled arrhythmias, tight stenotic valvular lesions)
- •Acute cardiovascular pathologies: acute/decompensated heart failure, acute coronary syndrome
- •Uncontrolled hypertension (systolic blood pressure>150 mmHg)
- •Preoperative HR more than 110 bpm despite proper fluid management and patients with renal impairment
- •Renal impairment
- •Patients on vasopressor infusion,
- •Allergy of any of the study drugs
研究组 & 干预措施
ephedrine
ephedrine boluses
干预措施: Ephedrine (Drug)
control
Normal Saline boluses
干预措施: Normal Saline (Drug)
结局指标
主要结局
incidence of postinduction hypotension
时间窗: from induction of anesthesia until 20 minutes after induction
mean arterial pressure \< 65 mmHg
次要结局
- area under mean arterial pressure of 65 mmHg(from induction of anesthesia until 20 minutes after induction)