Plasma Gabapentin Concentration During and Following Cardiac Bypass

Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01022736

Enrollment

Registered

2009-12-01

Start date

2007-05-31

Completion date

2007-09-30

Last updated

2009-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass

Keywords

gabapentin, pharmacokinetics, visual analogue pain scale, cardiopulmonary bypass

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.

Interventions

DRUGGabapentin

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026