Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Rambam Health Care Campus

Status and phase: Terminated; Phase 4

Conditions: Bariatric Surgery Candidate

Treatments: Drug: Paracetamol; Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)

Study type: Interventional

Funder types: Other

Identifiers

NCT03161509

0563-16-RMB

Details and patient eligibility

About

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Full description

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects.

Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Enrollment: 2 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. BMI over 30 and eligible for sleeve gastrectomy
2. Mentally capable for consent
3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

Exclusion criteria

1. Gastrointestinal illness impairing absorption
2. renal failure (glomerular filtration rate<45)
3. liver cirrhosis
4. heart failure (New York Heart Association class III or IV)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

paracetamol

Experimental group

Description:

10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy

Treatment:

Drug: Paracetamol

antiepileptic drug

Experimental group

Description:

Up to 10 participants in each drug (up to 4 medications, total of up to 40 participants) will undergo measurement of levels of their chronic medication after a dose before and after sleeve gastrectomy

Treatment:

Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)