Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.

Launched by UNIVERSITY HOSPITAL, GHENT · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how the body processes and responds to intravenous paracetamol (also known as acetaminophen) in both morbidly obese and non-obese patients. The goal is to determine the right dose of paracetamol for effective pain relief, especially since obese patients might require higher amounts due to differences in how their bodies handle the medication. Researchers will look at blood samples over 30 hours to see how the levels of paracetamol and its by-products compare to predictions made by an existing model. They will also test a new, easier way to collect blood samples from the finger to see if it provides similar results to traditional venous blood tests.

To participate in this study, individuals must be adults aged 18 to 69, scheduled for laparoscopic surgery, and either classified as obese (with a higher body mass index or BMI) or non-obese (with a normal BMI). Participants will need to provide informed consent and will undergo liver and kidney function tests before and after receiving paracetamol. The study is currently looking for volunteers, and it’s important to note that certain health conditions, like liver disease or allergies to paracetamol, may exclude someone from participating. This research could lead to safer and more effective pain management for obese patients in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adult ≥ 18 \< 70 years old (obese patients) Adult ≥ 18 years old (non-obese patients)
• • 2. Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial
• • 3. Obese scheduled for laparoscopic bariatric surgery Non obese scheduled for laparoscopic surgery
• • 4. Control group BMI ≥18.5 en \<30 kg.m-2 or Obese group BMI \> 35kg.m-2
• • 5. ASA Class I, II or III as assigned by the anaesthesiologist
• Exclusion Criteria:
• • 1. Allergy or inability to tolerate "paracetamol"
• • 2. Documented Liver disease or liver enzymes \> 3X normal value
• • 3. Kidney disease (eGFR \< 30ml.min-1)
• • 4. Participation in a clinical trial within the past 30 days
• • 5. Chronic alcohol abuse or alcohol intake \<72hrs
• • 6. Gilbert-Meulengracht-syndroom
• • 7. Chronic malnutrition
• • 8. Intake of medication with influence on CYP2E1 or UDP-glucuronosyltransferase
• • 9. Pregnancy