Pharmacokinetics of Acetaminophen in Morbidly Obese Patients (APAP)

St. Antonius Hospital

Status and phase

Completed

Phase 4

Conditions

Morbid Obesity

Treatments

Drug: acetaminophen 2 g

Study type

Interventional

Funder types

Other

Identifiers

NCT01764555

2012-000956-32 (EudraCT Number)

APAP study

Details and patient eligibility

About

This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation

Enrollment

28 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for morbidly obese patients:

BMI > 40 kg/m2 undergoing bariatric surgery.
Patients between 18 - 60 years old
ASA physical classification of II or III
All racial and ethnic groups will be included

Inclusion criteria for control group:

BMI between 18 and 25 kg/m2 undergoing general surgery
Patients between 18 - 60 years old
ASA (American Society of Anesthesiology) physical classification of I, II or III
All racial and ethnic groups will be included

Exclusion criteria for all study arms:

Renal insufficiency
Liver disease
Patients with Gilbert-Meulengracht syndrome
Chronic alcohol intake or use of alcohol within last 72 hours
Pregnancy or breastfeeding
Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
Diabetes mellitus type II patients
Smoking
Acetaminophen intake before the study (24 hours before study)