Actively Recruiting
Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.
Led by University Hospital, Ghent · Updated on 2024-08-12
70
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 CYP2E1 pathway. Its activity is induced by obesity, potentially endangering the safety profile of APAP. Metabolic-dysfunction associated liver disease (MASLD) is an important associated risk factor for APAP induced-hepatotoxicity. The primary endpoint of this study is to validate Van Rongen's prediction model on plasma concentration of paracetamol and its metabolites and extend it to the steady state phase over a period of 30 hours by measuring plasma concentrations of paracetamol and its metabolites and comparing them with the plasma concentrations predicted by the model by Van Rongen et al. In addition, results obtained from venous blood will be compared with results obtained via VAMS after finger stick. If VAMS correlates well with plasma concentrations of paracetamol and its NAPQI adducts, future interventional studies may utilize the patient-friendly VAMS technology in an effort to further investigate the safety and efficacy of higher doses of paracetamol in obese patients and possibly other patient groups. The secondary endpoints of this study are liver function tests before and after 30hrs of paracetamol administration, the VAS pain scores, the surgical pleth index (SPI) and the consumption of piritramide as recorded by a PCIA pump.
CONDITIONS
Official Title
Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 70 years (obese patients) and adults aged 18 years or older (non-obese patients)
- Able to understand and sign informed consent
- Obese patients scheduled for laparoscopic bariatric surgery
- Non-obese patients scheduled for elective laparoscopic surgery
- Control group BMI between 18.5 and 30 kg/m²
- Obese group BMI greater than 35 kg/m²
- ASA physical classification I, II, or III as assigned by the anesthesiologist
You will not qualify if you...
- Allergy or intolerance to paracetamol
- Documented liver disease or liver enzymes more than three times the normal value
- Kidney disease with eGFR less than 30 ml/min
- Participation in a clinical trial within the past 30 days
- Chronic alcohol abuse or alcohol intake within the last 72 hours
- Gilbert-Meulengracht syndrome
- Chronic malnutrition
- Use of medications that affect CYP2E1 or UDP-glucuronosyltransferase enzymes
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
L
Luc De Baerdemaeker, MD, PhD
CONTACT
A
Ann De Bruyne, study nurse
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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