NCT07466108

Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Paracetamol
• Hypotension Drug-Induced
• Emergency Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-18
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-03-12
• Last updated: 2026-03-20

Locations

1 site across 1 country: Egypt