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OpenTrials
Completed

NCT Number: NCT02901054

CSF Pharmacokinetics of Ondansetron

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 70 years old;
  • Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
  • Ability to provide informed consent

Exclusion criteria

  • Not giving consent to participate in the study;
  • Patients with history of or current hepatic or renal insufficiency;
  • Patients with BMI ≥ 33;
  • Patients with heart failure or active arrhythmias;
  • Patients with severe systemic disease that is a constant threat to life;
  • Contraindication or allergy to ondansetron;
  • Pregnancy or lactation.
  • Prisoners

Treatment and study plan

ondansetron

Drug

A single 15-min intravenous infusion of ondansetron

Other names: Zofran

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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