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Plasma Gabapentin Concentration During and Following Cardiac Bypass

NCT ID: NCT01022736

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Bypass

Keywords

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gabapentin pharmacokinetics visual analogue pain scale cardiopulmonary bypass

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gabapentin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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neurontin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Queen's University and Kingston General Hospital, Department of Anesthesiology & Perioperative Medicine

Principal Investigators

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Joel Parlow, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 20112079 (View on PubMed)

Other Identifiers

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ANAE-128-06

Identifier Type: -

Identifier Source: org_study_id