Plasma Gabapentin Concentration During and Following Cardiac Bypass

Queen's University

Status and phase: Completed; Phase 4

Conditions: Cardiopulmonary Bypass

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01022736

ANAE-128-06

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

gabapentin

Experimental group

Description:

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.

Treatment:

Drug: Gabapentin