Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy

Официальное название

Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Paracetamol (acetaminophen)
  Patients will receive 1 g intravenous paracetamol (prepared by withdrawing 100 mL of paracetamol into two 50 mL syringes). The drug will be infused at a rate of 600 mL/h to be completed over a period of 10 minutes
• Другое Placebo Control
  Patients will receive 100 mL saline 0.9% (prepared by withdrawing 100 mL of saline 0.9% into two 50 mL syringes). The dose will be infused at a rate of 600 mL/h.

Первичные конечные точки

• Mean arterial pressure [Срок оценки: 10 minutes after infusion of the study drug]

Вторичные конечные точки (3)

• drug induced hypotension [Срок оценки: from drug administration until 30 minutes after drug administration]
• Heart rate [Срок оценки: from drug administration until 30 minutes after drug administration]
• mean arterial pressure [Срок оценки: from drug administration until 30 minutes after drug administration]

Критерии участия

Критерии включения

• Adult patients, ASA I-III undergoing emergency laparotomy

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT07466108 · MD-404-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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