Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy

NCT07466108 | Recruiting

• 1 other identifier: MD-404-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure

  noninvasive mean arterial pressure

  10 minutes after infusion of the study drug

Secondary Outcomes (3)

• drug induced hypotension

  from drug administration until 30 minutes after drug administration

• Heart rate

  from drug administration until 30 minutes after drug administration

• mean arterial pressure

  from drug administration until 30 minutes after drug administration

Study Arms (2)

Paracetamol group

ACTIVE COMPARATOR

Drug: Paracetamol (acetaminophen)

Control group

PLACEBO COMPARATOR

Other: Placebo Control

Interventions

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

Paracetamol group

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.

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, ASA I-III undergoing emergency laparotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Maha Mostafa

CONTACT

+201000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)