CSF Pharmacokinetics of Ondansetron

Pain Clinical Trial

Official title:

Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901054
• Other study ID #: 201605080
• Status: Completed
• Phase: N/A
• Start date: August 25, 2016
• Est. completion date: November 17, 2016

Study information

• Verified date: December 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 17, 2016
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF to Plasma Concentration Ratio	CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample	0-180 min from the beginning of infusion