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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracetamol | Experimental | 10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy |
|
| antiepileptic drug | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | single dose of 1 gr paracetamol |
| |
| Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC | sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irit Hochberg, MD/PhD | Rambam Healthcare Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Healthcare Campus | Haifa | Israel |
IPD will be shared upon request
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000927 | Anticonvulsants |
| D000077213 | Lamotrigine |
| D010672 | Phenytoin |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy
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| Drug |
Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose |
|
|
| Aniline Compounds |
| D000588 | Amines |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |