IV paracetamol and blood pressure in adults having emergency laparotomy
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial
This trial will test whether a single dose of IV paracetamol causes drops in blood pressure in adults undergoing emergency laparotomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07466108 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for emergency laparotomy who are ASA I–III and hemodynamically stable will be randomized to receive IV paracetamol or placebo after standardized induction and maintenance of anesthesia. Preoperative fluid optimization will use passive leg raising to guide stroke-volume–directed boluses, and anesthesia will follow a set regimen (propofol, fentanyl, succinylcholine, isoflurane, atracurium). Heart rate and blood pressure will be recorded every 2 minutes for 20 minutes after drug administration, and predefined hypotension will be treated with 5-µg norepinephrine boluses repeated as needed. The trial excludes patients with significant cardiac disease, ongoing hemodynamic instability, high shock index, pregnancy or lactation, and drug allergies, and is conducted at Cairo University in Cairo, Egypt.
Who should consider this trial
Good fit: Ideal participants are adult (ASA I–III) patients undergoing emergency laparotomy who are hemodynamically stable prior to induction.
Not a fit: Patients with severe cardiac disease, current hypotension or vasopressor dependence, high shock index, pregnancy, or allergy to study drugs are excluded and unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, the results could clarify whether IV paracetamol is safe for blood pressure during emergency abdominal surgery and help guide perioperative analgesic choices.
How similar studies have performed: Observational data in critically ill patients have suggested paracetamol can cause hypotension, but randomized intraoperative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo, Cairo Governorate
- Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Maha Mostafa
- Email: maha.mostafa@cu.edu.eg
- Phone: +201000365115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.