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Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy

NCT07466108 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Paracetamol
  • Hypotension Drug-Induced
  • Emergency Surgery

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466108 on ClinicalTrials.gov