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

Status: Recruiting
Location: See location...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
View:

• 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

Locations
Other Locations
Belgium
University Hospital
RECRUITING
Ghent
Contact Information
Primary
Luc De Baerdemaeker, MD, PhD
luc.debaerdemaeker@ugent.be
09 332 3281
Backup
Ann De Bruyne, study nurse
ann.debruyne@ugent.be
09332 3281
Time Frame
Start Date: 2020-09-11
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 70
Treatments
obese patients WHO class > 2
patients with a BMI \> 35 undergoing laparoscopic surgery. venous and capillary blood samples are collected to determine the concentrations of acetaminophen and its metabolites after intravenous administration of a first dose of 2g acetaminophen and after a fifth dose of 1g acetaminophen in steady state conditions.
non obese and overweight patients
patients with a BMI between 18,5 - 30 undergoing laparoscopic surgery. Venous and capillary blood samples are collected to determine the concentrations of acetaminophen and its metabolites after intravenous administration of a first dose of 2g acetaminophen and after a fifth dose of 1g acetaminophen in steady state conditions.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov