Paracetamol, Hypotension Drug-Induced, Emergency Surgery
Conditions
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.
Detailed description
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.
Interventions
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
OTHERPlacebo 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
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure | 10 minutes after infusion of the study drug | noninvasive mean arterial pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| drug induced hypotension | from drug administration until 30 minutes after drug administration | mean arterial pressure ≤ 70% of the baseline reading and/or \<65 mmHg |
| Heart rate | from drug administration until 30 minutes after drug administration | — |
| mean arterial pressure | from drug administration until 30 minutes after drug administration | — |
Countries
Egypt
Contacts
CONTACTMaha Mostafa
Outcome results
None listed