Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean arterial pressure
研究概览
简要总结
Emergency laparotomy is a high-risk procedure often performed in patients with severe physiological derangements due to sepsis, making perioperative management challenging. Although multimodal analgesia is essential, options are often limited by factors such as hemodynamic instability, renal dysfunction, and coagulopathy. Intravenous paracetamol is commonly recommended for perioperative analgesia because of its opioid-sparing effect, but evidence suggests it may cause hypotension through peripheral vasodilation, particularly in critically ill patients. Most data on this effect come from observational studies, and evidence regarding its intraoperative hemodynamic impact remains limited.
详细描述
Preoperative fluid administration will be guided by stroke volume change after passive leg raising maneuver Patients will receive propofol 2 mg/kg and fentanyl 1 µg/kg for induction, followed by succinylcholine 1 mg/kg for intubation. Anesthesia will be maintained with isoflurane (end-tidal 1.2%) and atracurium 0.5 mg/kg, then 0.1 mg/kg every 20 minutes.
After administration of the study drug (paracetamol or placebo), Heart rate and blood pressure will be monitored at 2 min intervals for 20 min. If patients developed hypotension (mean arterial pressure [MAP] ≤ 70% of the baseline reading and/or <65 mmHg), a 5-mcg bolus of norepinephrine will be given. The norepinephrine bolus will be repeated if mean arterial pressure was not restored within 2 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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, ASA I-III undergoing emergency laparotomy
排除标准
- •Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, arrhythmias, tight valvular lesions)
- •Hemodynamically unstable patients (defined as patients with MAP < 65 mmHg or need vasopressor to maintain MAP>65 mmHg).
- •Patients with high shock index (heart rate / systolic blood pressure >1)
- •Pregnant or lactating women,
- •Allergy of any of the study drugs
研究组 & 干预措施
Paracetamol group
干预措施: Paracetamol (acetaminophen) (Drug)
Control group
干预措施: Placebo Control (Other)
结局指标
主要结局
Mean arterial pressure
时间窗: 10 minutes after infusion of the study drug
noninvasive mean arterial pressure
次要结局
- Heart rate(from drug administration until 30 minutes after drug administration)
- mean arterial pressure(from drug administration until 30 minutes after drug administration)
- drug induced hypotension(from drug administration until 30 minutes after drug administration)