Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

NCT03161509 — Phase 4, Terminated, 2 participants, Rambam Health Care Campus

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Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs

Registry	NCT03161509
Status	Terminated - publication of better study
Phase	Phase 4
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	2 (Actual)
Sponsor	Rambam Health Care Campus (Other)
Conditions	Bariatric Surgery Candidate
Interventions	Paracetamol, Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) (Drug)
Dates	start 2017-07-01, primary completion 2018-12-01, completion 2019-01-01, first posted 2017-05-19, last updated 2021-09-24
Locations	1 site in Israel

-Summary

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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
paracetamol	Experimental	Drug: Paracetamol	10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy
antiepileptic drug	Experimental	Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)	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

Paracetamol (Drug): single dose of 1 gr paracetamol
Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) (Drug), also known as Antiepileptic: Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose

+Outcome measures

Primary outcomes

Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC [8 hours]: sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC

+Eligibility

Sex: All, ages: 18 Years to 70 Years, 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)

+Locations (1)

Facility	City	Country	Status
Rambam Healthcare Campus	Haifa	Israel

+Investigators

Irit Hochberg, MD/PhD, Principal investigator, Rambam Healthcare Campus