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.

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Key information

Conditions

Cardiopulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kingston General Hospital

Kingston, Ontario, K 7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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 names: neurontin

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Dec 1, 2009
Registry last updated: Dec 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed