5 Versus 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery
2026年8月4日 更新者：Ahmed Hasanin、Cairo University
Comparing 5 mcg and 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery: a Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
136
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Maha Mostafa, MD
- 电话号码：+201000365115
- 邮箱：maha.mostafa@cu.edu.eg
学习地点
-
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Cairo Governorate
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Cairo、Cairo Governorate、埃及
- 招聘中
- Cairo University
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接触：
- ahmed Hasanin, Lecturer
- 电话号码：+2010095076954
- 邮箱：ahmedmohamedhasanin@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
Norepinephrine dose of 5 mcg will be given if patient developed hypotension (mean arterial pressure <65 mmHg).
The norepinephrine bolus (5 mcg) will be repeated if mean arterial pressure is not restored within 2 min.
Norepinephrine infusion will be started if hypotension persisted after three boluses.
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有源比较器：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.
|
Norepinephrine dose of 10 mcg will be given if patient developed hypotension (mean arterial pressure <65 mmHg).
The norepinephrine bolus (10 mcg) will be repeated if mean arterial pressure is not restored within 2 min.
Norepinephrine infusion will be started if hypotension persisted after three boluses.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of successfully managed hypotensive episode
大体时间：from 0 min of induction of anesthesia until 30 min after skin incision
|
mean arterial pressure >65 mmHg within 2 min of drug administration
|
from 0 min of induction of anesthesia until 30 min after skin incision
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area under a mean arterial pressure of 65 mmHg
大体时间：from 0 min of induction of anesthesia until 30 min after skin incision
|
The area under a mean arterial pressure (MAP) of 65 mm Hg will be calculated by subtracting MAP measurements from 65 mm Hg, multiplying positive differences with the time difference (in minutes) between this MAP measurement and the consecutive MAP measurement, and summing the values
|
from 0 min of induction of anesthesia until 30 min after skin incision
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Duration of MAP<65 mmHg
大体时间：from 0 min after induction of anesthesia until 30 min after skin incision
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in minutes
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from 0 min after induction of anesthesia until 30 min after skin incision
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bradycardia
大体时间：from 0 min after induction of anesthesia until 30 min after skin incision
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heart rate < 50 bpm following drug administration
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from 0 min after induction of anesthesia until 30 min after skin incision
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|
hypertension
大体时间：from 0 min after induction of anesthesia until 30 min after skin incision
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systolic blood pressure >120% of baseline following drug administration
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from 0 min after induction of anesthesia until 30 min after skin incision
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月4日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年7月17日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MS-303-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
data related to this research is available form the PI upon reasonable request
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.