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NCT Number: NCT07466108

Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy

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.

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Key information

Conditions

Paracetamol Cardiovascular Diseases Emergency Surgery Hypotension Hypotension Drug-Induced Vascular Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

ahmed Hasanin, Lecturer

CONTACT

[email protected]

+2010095076954

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol (acetaminophen)

Drug

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

Placebo control

Other

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 outcomes

  1. Mean arterial pressure

    Time frame: 10 minutes after infusion of the study drug

    noninvasive mean arterial pressure

Secondary outcomes

  1. drug induced hypotension

    Time frame: from drug administration until 30 minutes after drug administration

    mean arterial pressure ≤ 70% of the baseline reading and/or <65 mmHg

  2. Heart rate

    Time frame: from drug administration until 30 minutes after drug administration

  3. mean arterial pressure

    Time frame: from drug administration until 30 minutes after drug administration

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Mostafa

CONTACT

[email protected]

+201000365115

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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