CSF Pharmacokinetics of Ondansetron

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Ondansetron

• Registration Number: NCT02901054
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-25
• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Primary Completion: 2016-11-17
• Study Completion: 2016-11-17
• Results First Submitted: 2018-02-27
• Results First Submitted QC: 2018-04-16
• Results First Posted: 2018-05-16
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label infusion ondansetron	Ondansetron	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States