Actively Recruiting
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial
Led by Cairo University · Updated on 2026-03-20
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the hemodynamic effects of intravenous paracetamol in adult patients undergoing emergency laparotomy, a high-risk surgery often complicated by severe physiological disturbances like sepsis. The study addresses concerns about paracetamol's potential to cause hypotension through peripheral vasodilation, especially in critically ill patients, where evidence from intraoperative settings remains limited. Participants will be randomly assigned to receive either 1 gram of intravenous paracetamol infused over 10 minutes or a placebo consisting of saline. Before surgery, fluid administration will be guided by stroke volume changes after a passive leg raising test. Anesthesia will be induced and maintained using specified doses of propofol, fentanyl, succinylcholine, isoflurane, and atracurium. Blood pressure and heart rate will be closely monitored every 2 minutes for 20 minutes after drug administration. Hypotension will be treated with norepinephrine boluses as needed. Throughout the study, mean arterial pressure will be measured primarily 10 minutes after the infusion of the study drug. Secondary outcomes include tracking drug-induced hypotension, heart rate, and mean arterial pressure up to 30 minutes post-infusion. The trial includes continuous assessment of vital signs and response to potential hypotensive events. Participation is expected to last throughout the surgical procedure and immediate monitoring period following the drug infusion.
CONDITIONS
Brief Title
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 21 to 65 years
- Classified as ASA physical status I to III
- Undergoing emergency laparotomy surgery
You will not qualify if you...
- Severe cardiac problems such as impaired heart function with ejection fraction below 40%, heart block, arrhythmias, or severe valve disease
- Hemodynamically unstable patients with mean arterial pressure below 65 mmHg or requiring vasopressors
- Patients with a high shock index (heart rate divided by systolic blood pressure greater than 1)
- Pregnant or breastfeeding women
- Allergy to any study drugs used in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 30 minutes
Participants receive an intravenous infusion of either paracetamol or a placebo during emergency laparotomy surgery. Heart rate and blood pressure are monitored closely after the infusion to observe hemodynamic effects.
1 treatment visit during surgery with monitoring every 2 minutes for 20 minutes
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Cairo Governorate, Egypt
Actively Recruiting
Research Team
M
Maha Mostafa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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