Comparing 5 mcg and 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Incidence of successfully managed hypotensive episode
研究概览
简要总结
Postinduction hypotension is a frequent intraoperative complication, particularly in emergency abdominal surgery due to factors such as sepsis, hypovolemia, and limited preoperative cardiac assessment. Because it can lead to serious organ injury, prompt prevention and management are essential. Vasopressors, including ephedrine, phenylephrine, and norepinephrine, are commonly used, with NE gaining interest as an intraoperative bolus despite uncertainty about the optimal dose in general surgery population The aim of this study is to compare 5 mcg to 10 mcg norepinephrine bolus for treatment of postinduction hypotension and early intraoperative in emergency abdominal surgery.
详细描述
fluid assessment using stroke volume change after passive leg raising maneuver will be applied. If stroke volume increase >10%, 500-mL bolus of lactated ringer will be given. Passive leg raising will be repeated until the patient is non-responder or 1500 mL were infused.
intraoperatively, heart rate and blood pressure will be monitored at 2 min intervals until 30 min after skin incision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery
排除标准
- •Severe cardiac morbidities (impaired contractility with ejection fraction < 45%, heart block, arrhythmias, tight valvular lesions)
- •Patients on vasopressor infusion,
- •Pregnant or lactating women,
- •Allergy of any of the study drugs
研究组 & 干预措施
Norepinephrine 10-mcg group
The study drug will be prepared by diluting 4000 mcg of NE in 400 mL of normal saline to achieve a concentration of 10 mcg/mL. The assigned dose (10 mcg, 1 mL of the prepared solution) will then be further diluted with normal saline in a 10-mL syringe.
干预措施: Norepinephrine 10 mcg (Drug)
Norepinephrine 5-mcg group
The study drug will be prepared by diluting 4000 mcg of NE in 400 mL of normal saline to achieve a concentration of 10 mcg/mL. The assigned dose (5 mcg, 0.5 mL of the prepared solution) will then be further diluted with normal saline in a 10-mL syringe.
干预措施: Norepinephrine 5 mcg (Drug)
结局指标
主要结局
Incidence of successfully managed hypotensive episode
时间窗: from 0 min of induction of anesthesia until 30 min after skin incision
mean arterial pressure \>65 mmHg within 2 min of drug administration
次要结局
- Area under a mean arterial pressure of 65 mmHg(from 0 min of induction of anesthesia until 30 min after skin incision)
- Duration of MAP<65 mmHg(from 0 min after induction of anesthesia until 30 min after skin incision)
- bradycardia(from 0 min after induction of anesthesia until 30 min after skin incision)
- hypertension(from 0 min after induction of anesthesia until 30 min after skin incision)