ParacetamolNCT07466108
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
A study testing Paracetamol (acetaminophen) in people with Paracetamol and Hypotension Drug-Induced, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Paracetamol, Hypotension Drug-Induced, Emergency Surgery
- What is being tested?
- Paracetamol (acetaminophen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, ASA I-III undergoing emergency laparotomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Cairo Governorate
ahmed Hasanin, Lecturer, +2010095076954, ahmedmohamedhasanin@gmail.com
About this study
Official title: Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Paracetamol, Hypotension Drug-Induced, Emergency Surgery
- Being tested
- Paracetamol (acetaminophen), Placebo Control
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol group | Active comparator | Not described Receives: Drug: Paracetamol (acetaminophen) |
| Control group | Placebo comparator | Not described Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
noninvasive mean arterial pressure
Measured: 10 minutes after infusion of the study drug
Secondary outcomes (3)
drug induced hypotension
mean arterial pressure ≤ 70% of the baseline reading and/or <65 mmHg
Measured: from drug administration until 30 minutes after drug administration
Heart rate
Measured: from drug administration until 30 minutes after drug administration
mean arterial pressure
Measured: from drug administration until 30 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start18 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParacetamolStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466108
- Sponsor's protocol ID
- MD-404-2025
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data related to this research will be available from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07466108
- Acronym / sponsor ID
- MD-404-2025
- Conditions
- Paracetamol, Hypotension Drug-Induced, Emergency Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol group | Active comparator | Drug: Paracetamol (acetaminophen) |
| Control group | Placebo comparator | Other: Placebo Control |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients, ASA I-III undergoing emergency laparotomy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol (acetaminophen)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 | Drug | Paracetamol group |
| Placebo ControlPatients 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. | Other | Control group |
Primary outcome
Mean arterial pressure
Time frame: 10 minutes after infusion of the study drug
noninvasive mean arterial pressure
3 secondary outcomes
drug induced hypotension
Time frame: from drug administration until 30 minutes after drug administration
Heart rate
Time frame: from drug administration until 30 minutes after drug administration
mean arterial pressure
Time frame: from drug administration until 30 minutes after drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. data related to this research will be available from the PI upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol (acetaminophen) in people with Paracetamol and Hypotension Drug-Induced, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Mostafa (+201000365115, maha.mostafa@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: 10 minutes after infusion of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.