Plasma Gabapentin Concentration During and Following Cardiac Bypass

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT01022736
First received: November 27, 2009
Last updated: December 7, 2009
Last verified: December 2009
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Queen's University

Additional 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
Study First Received: November 27, 2009
Last Updated: December 7, 2009
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 20, 2014