Plasma Gabapentin Concentration During and Following Cardiac Bypass

Study Overview
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Brief Summary
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This open label investigation is to determine whether cardiopulmonary bypass affects plasma gabapentin concentration after preoperative administration in the setting of cardiac bypass surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before separation from bypass, 30 minutes following bypass and then before and 2 hours following each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and morphine equivalents will be documented for one day following surgery.

Official Title
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Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass

Conditions
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Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for cardiac bypass surgery involving median sternotomy and CPB signed informed consent Exclusion Criteria: history of chronic pain regular opioid consumption regular anticonvulsant consumption regular gabapentin or pregabalin use recent congestive heart failure ejection fraction <35% chronic pulmonary disease liver disease renal insufficiency (preoperative creatinine > 140umol/L history of adverse reaction to acetaminophen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gabapentin<br>patients scheduled for cardiac bypass surgery will be administered gabapentin (600mg, orally). Blood will be drawn and plasma gabapentin levels determined 1 hour before surgery, 10 minutes into surgery, 10 minutes before separation from bypass, 30 minutes following bypass, and then before and 2 hours after each dose of gabapentin. | Drug: Gabapentin<br>* Subjects will be administered gabapentin (600 mg, orally) 1 hour prior to cardiac bypass surgery, 1 hour following extubation, then every 8 hours for a total of 4 doses.<br>* Other names: neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentrations of gabapentin |  | 1 hour before surgery, 10 min following initiation of bypass, 10 min before separation from bypass, 30 min following bypass, and then before and 2 hours following each of the next 3 doses of gabapentin | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gabapentin, pharmacokinetics, visual analogue pain scale, cardiopulmonary bypass