Pharmacokinetics of Paracetamol before and after Roux-en-Y gastric bypass

Phase 4

Recruiting

Conditions: Roux en Y gastric bypass
gastric bypass
10017998

Registration Number: NL-OMON55190

Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

- at least 18 years old
- on the waiting list of getting a Roux en Y gastric bypass
- mentally competent
- provided informed consent

Exclusion Criteria

- patient undergoing different types of bariatric surgery, such as gastric
band, gastric sleeve, mini gastric bypass or revision RYGB
- patient who previously underwent a gastric surgery, such as gastric band,
RYGB or gastric sleeve
- liver failure
- taken paracetamol <24 h before blood sampling at t=0
- allergy or intolerance for paracetamol
- not being able to take paracetamol orally
- to vomit after intake of paracetamol
- to be pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is the pharmacokinetics of paracetamol after a single<br /><br>oral dose of 1000 mg paracetamol before and after RYGB.<br /><br><br /><br>Amendement:<br /><br>In 6 RYGB patients the primaire end point is the pharmacokinetics of<br /><br>paracetamol after a single oral dose of 1000 mg paracetamol, followed by a<br /><br>single intravenous dose of 1000 mg paracetamol at 6 months after RYGB.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secundary end point will be the pharmacokinetics of the metabolites<br /><br>paracetamol glucuronide (PCM-GLU), paracetamol sulfate (PCM-SUL), paracetamol<br /><br>mercatopurate (PCM-MER) and paracetamol cysteine (PCM-CYS).<br /><br><br /><br>Additional secundary end points are aspartate aminotransferase (ASAT), alanine<br /><br>aminotransferase (ALAT), gamma-glutamyltransferase (γ-GT) and bilirubin values<br /><br>before, after 6h and 24h after a single oral dose of 1000 mg paracetamol before<br /><br>and after RYGB.</p><br>