CSF Pharmacokinetics of Ondansetron

The Washington University

Status: Completed

Conditions: Pain

Treatments: Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02901054

201605080

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

open label infusion ondansetron

Experimental group

Description:

1. A single 4-mL CSF sample per subject. 2. Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration

Treatment:

Drug: Ondansetron