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Plasma Gabapentin Concentration During and Following Cardiac Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022736
First Posted: December 1, 2009
Last Update Posted: December 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Queen's University
  Purpose
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.

Condition Intervention Phase
Cardiopulmonary Bypass Drug: Gabapentin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: May 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gabapentin
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
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 Name: neurontin

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022736


Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K 7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Joel Parlow, MD Queen's University and Kingston General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Joel Parlow, Queen's University and Kingston General Hospital, Department of Anesthesiology & Perioperative Medicine
ClinicalTrials.gov Identifier: NCT01022736     History of Changes
Other Study ID Numbers: ANAE-128-06
First Submitted: November 27, 2009
First Posted: December 1, 2009
Last Update Posted: December 8, 2009
Last Verified: December 2009

Keywords provided by Queen's University:
gabapentin
pharmacokinetics
visual analogue pain scale
cardiopulmonary bypass

Additional relevant MeSH terms:
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents