Status:
RECRUITING
Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.
Lead Sponsor:
University Hospital, Ghent
Conditions:
Acetaminophen Toxicity
Obesity, Morbid
Eligibility:
All Genders
18-70 years
Brief Summary
Obese patients may need higher doses of acetaminophen (APAP) for adequate analgesia, due to increased total clearance and distribution volume. APAP-induced hepatotoxicity is mainly caused through CYP2...
Detailed Description
A. Pharmacokinetics and pharmacodynamics of Intravenous Paracetamol in morbidly obese and non- obese patients. Study design: interventional, stratified, controlled, prospective cohort trial B. Hypot...
Eligibility Criteria
Inclusion
- Adult ≥ 18 \< 70 years old (obese patients) Adult ≥ 18 years old (non-obese patients)
- Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial
- Obese scheduled for laparoscopic bariatric surgery Non obese scheduled for laparoscopic surgery
- Control group BMI ≥18.5 en \<30 kg.m-2 or Obese group BMI \> 35kg.m-2
- ASA Class I, II or III as assigned by the anaesthesiologist
Exclusion
- Allergy or inability to tolerate "paracetamol"
- Documented Liver disease or liver enzymes \> 3X normal value
- Kidney disease (eGFR \< 30ml.min-1)
- Participation in a clinical trial within the past 30 days
- Chronic alcohol abuse or alcohol intake \<72hrs
- Gilbert-Meulengracht-syndroom
- Chronic malnutrition
- Intake of medication with influence on CYP2E1 or UDP-glucuronosyltransferase
- Pregnancy
Key Trial Info
Start Date :
September 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06549062
Start Date
September 11 2020
End Date
January 1 2025
Last Update
August 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000