Plasma Gabapentin Concentration During and Following Cardiac Bypass

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

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: gabapentin
  • 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.

Primary Measures

• plasma concentrations of gabapentin
  • Time Frame: 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Queen's University Other

Overall Clinical Trial Officials and Contacts

Joel Parlow, MD Principal Investigator Queen's University and Kingston General Hospital  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01022736

Study ID Number: ANAE-128-06

ClinicalTrials.gov Identifier: NCT01022736

Health Authority: Canada: Health Canada