Study of How Intravenous Paracetamol Works and Is Processed in Morbidly Obese and Non-Obese Patients Undergoing Laparoscopic Surgery

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 methods 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.

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