Plasma Gabapentin Concentration During and Following Cardiac Bypass

Cardiopulmonary Bypass Clinical Trial

Official title:

Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022736
• Other study ID #: ANAE-128-06
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2009
• Last updated: December 7, 2009
• Start date: May 2007
• Est. completion date: September 2007

Study information

• Verified date: December 2009
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

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.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No