CSF Pharmacokinetics of Ondansetron

Washington University School of Medicine19 enrolled

Overview

Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution. Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pain

Interventions

OndansetronDRUG

A single 15-min intravenous infusion of ondansetron

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 70 years old; 2. Patients planned to undergo hip or knee arthroplasty with spinal anesthesia; 3. Ability to provide informed consent Exclusion Criteria: 1. Not giving consent to participate in the study; 2. Patients with history of or current hepatic or renal insufficiency; 3. Patients with BMI ≥ 33; 4. Patients with heart failure or active arrhythmias; 5. Patients with severe systemic disease that is a constant threat to life; 6. Contraindication or allergy to ondansetron; 7. Pregnancy or lactation. 8. Prisoners

Locations (1)

Washington University in St. Louis

St Louis, Missouri, United States

Outcomes

Primary Outcomes

CSF to Plasma Concentration Ratio

CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample

Time frame: 0-180 min from the beginning of infusion

Data from ClinicalTrials.gov

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