Morbidly Obese Patients Exhibit Increased CYP2E1-Mediated Oxidation of Acetaminophen.
Anne van Rongen, Pyry A J Välitalo, Mariska Y M Peeters...
https://pubmed.ncbi.nlm.nih.gov/26818482Actively Recruiting
Age: 18Years - 70Years
All Genders
ID06549062
Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol/Acetaminophen in Morbidly Obese and Non-Obese Patients
Led by University Hospital, Ghent · Updated on 2024-08-12
70
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating how intravenous paracetamol (acetaminophen) behaves and works in morbidly obese and non-obese patients undergoing laparoscopic surgery. The study aims to validate a prediction model for blood levels of paracetamol and its metabolites over 30 hours and explore the safety concerns related to higher doses in obese patients, especially regarding liver toxicity linked to metabolic dysfunction-associated liver disease. The study also compares traditional venous blood sampling with a new minimally invasive finger stick method called Volumetric Absorptive MicroSampling (VAMS). Participants receive standard care doses of intravenous paracetamol: a 2g loading dose after anesthesia induction, followed by 1g every 6 hours up to 30 hours. Both obese patients (BMI > 35) and non-obese patients (BMI 18.5-30) undergoing laparoscopic surgery are included. Blood samples are collected at multiple time points from veins and capillaries to measure paracetamol and its toxic metabolites. Pain relief is supported with intravenous ibuprofen and a patient-controlled analgesia pump delivering piritramide. Liver function tests are done before and after the 30-hour period. During the study, participants have blood drawn at scheduled intervals up to 30 hours to monitor drug levels and liver markers. Pain is assessed using Visual Analog Scale (VAS) scores and the Surgical Pleth Index (SPI) both at rest and after movement. The amount of piritramide used is recorded to evaluate analgesic needs. The researchers compare measured drug concentrations to model predictions and assess the VAMS method's accuracy. Data analysis includes statistical tests to explore differences between groups and validate the sampling methods. Total participation covers the 30-hour postoperative monitoring period.
CONDITIONS
Brief Title
Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years for obese patients; adults aged 18 years and older for non-obese patients
- Able to understand and sign informed consent
- Obese patients scheduled for laparoscopic bariatric surgery with BMI over 35 kg/m2
- Non-obese patients scheduled for elective laparoscopic surgery with BMI between 18.5 and less than 30 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 3 times the normal value
- Kidney disease with estimated glomerular filtration rate less than 30 ml/min
- Participation in another clinical trial within the past 30 days
- Chronic alcohol abuse or alcohol use within the past 72 hours
- Gilbert-Meulengracht syndrome
- Chronic malnutrition
- Use of medications affecting CYP2E1 or UDP-glucuronosyltransferase enzymes
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 30 hours
Participants receive intravenous paracetamol and standard analgesia during and after laparoscopic surgery. Blood samples are collected to measure paracetamol and metabolite concentrations at multiple timepoints up to 30 hours after the first dose. Pain scores and surgical pleth index are also monitored.
1 surgical hospitalization including multiple blood sampling timepoints and assessments over 30 hours
Follow-up
Duration - Up to 30 hours or until hospital discharge
Participants are monitored for liver function changes and pain control until discharge from the hospital, with assessments of liver enzymes, pain scores, and analgesia consumption.
Continuous monitoring during hospitalization with assessments at specified timepoints
Trial Site Locations
Total: 1 location
1
University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
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Research Team
L
Luc De Baerdemaeker, MD, PhD
A
Ann De Bruyne, study nurse
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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