Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paracetamol (acetaminophen), Placebo Control.
- Who it may be relevant to
- Registry conditions: Paracetamol, Hypotension Drug-Induced, Emergency Surgery. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Drug 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 - Other 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.
Primary outcome measures
- Mean arterial pressure [Time frame: 10 minutes after infusion of the study drug]
Secondary outcome measures (3)
- drug induced hypotension [Time frame: from drug administration until 30 minutes after drug administration]
- Heart rate [Time frame: from drug administration until 30 minutes after drug administration]
- mean arterial pressure [Time frame: from drug administration until 30 minutes after drug administration]
Eligibility criteria
Inclusion criteria
- Adult patients, ASA I-III undergoing emergency laparotomy
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07466108 · MD-404-2025