CSF Pharmacokinetics of Ondansetron

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.

Full Title of Study: “Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: November 17, 2016

Interventions

• Drug: Ondansetron
  • A single 15-min intravenous infusion of ondansetron

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• CSF to Plasma Concentration Ratio
  • Time Frame: 0-180 min from the beginning of infusion
  • CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Washington University School of Medicine
• Provider of Information About this Clinical Study
  • Principal Investigator: simon.haroutounian, Assistant Professor – Washington University School of Medicine
• Overall Official(s)
  • Simon Haroutounian, PhD, Principal Investigator, Dept of Anesthesiology, Washington Univ School of Medicine