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CSF Pharmacokinetics of Ondansetron

NCT ID: NCT02901054

Last Updated: 2019-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-25

Study Completion Date

2016-11-17

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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open label infusion 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

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

A single 15-min intravenous infusion of ondansetron

Interventions

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Ondansetron

A single 15-min intravenous infusion of ondansetron

Intervention Type DRUG

Other Intervention Names

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Zofran

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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simon.haroutounian

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Haroutounian, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Anesthesiology, Washington Univ School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201605080

Identifier Type: -

Identifier Source: org_study_id