Plasma Gabapentin Concentration During and Following Cardiac Bypass

NCT01022736 | Completed Phase 4

• 1 other identifier: ANAE-128-06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass

Keywords

gabapentin; pharmacokinetics; visual analogue pain scale; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

gabapentin

EXPERIMENTAL

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.

Drug: Gabapentin

Interventions

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.

Also known as: neurontin

gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for cardiac bypass surgery involving median sternotomy and CPB
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K 7L 2V7, Canada

Location

Related Publications (1)

• Parlow J, Gilron I, Milne B, Dumerton-Shore D, Orr E, Phelan R. Cardiopulmonary bypass does not affect plasma concentration of preoperatively administered gabapentin. Can J Anaesth. 2010 Apr;57(4):337-42. doi: 10.1007/s12630-010-9269-5. Epub 2010 Jan 29.

  PMID: 20112079 DERIVED

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Joel Parlow, MD

  Queen's University and Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2009
• First Posted: December 1, 2009
• Study Start: May 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: December 8, 2009

Record last verified: 2009-12

Locations

CA (1)