Plasma Gabapentin Concentration During and Following Cardiac Bypass

Phase 4

Completed

• Conditions: Cardiopulmonary Bypass
• Interventions: Drug: Gabapentin

• Registration Number: NCT01022736
• Lead Sponsor: Queen's University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Status Verified: 2009-12
• Study First Posted: 2009-12-01
• Last Update Submitted: 2009-12-07
• Last Update Posted: 2009-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gabapentin	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada