Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients, ASA I-III undergoing emergency laparotomy
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Paracetamol (acetaminophen)
DrugPatients 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
Placebo Control
Other interventionPatients 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Paracetamol groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean arterial pressure
noninvasive mean arterial pressure
Time frame
10 minutes after infusion of the study drugSecondary outcomes
1
drug induced hypotension
mean arterial pressure ≤ 70% of the baseline reading and/or \<65 mmHg
Time frame
from drug administration until 30 minutes after drug administration2
Heart rate
Time frame
from drug administration until 30 minutes after drug administration3
mean arterial pressure
Time frame
from drug administration until 30 minutes after drug administrationSponsors and contacts
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Source ClinicalTrials.gov