Plasma Gabapentin Concentration During and Following 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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.
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.
Other Name: neurontin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022736
|Kingston General Hospital|
|Kingston, Ontario, Canada, K 7L 2V7|
|Principal Investigator:||Joel Parlow, MD||Queen's University and Kingston General Hospital|