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The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass

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ClinicalTrials.gov Identifier: NCT01619436
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.

Condition or disease Intervention/treatment Phase
Glycemia During Coronary Artery Bypass Graft Sedation During Pre-anesthetic Medication Drug: Clonidine Drug: Ringer lactato Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.
Study Start Date : January 2011
Primary Completion Date : January 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: clonidine
clonidine 2 mg/kg IV
Drug: Clonidine
bolus, clonidine 2 mg/kg IV
Placebo Comparator: ringer lactato 1 ml
Ringer lactato 1 ml IV as Placebo
Drug: Ringer lactato
1 ML ringer lactato IV, as placebo


Outcome Measures

Primary Outcome Measures :
  1. sedation [ Time Frame: 2 years ]
    Clonidine 2 mg/kg IV. assessment sedation with Ransay scale


Secondary Outcome Measures :
  1. Glycemia [ Time Frame: 2 years ]
    clonide 2 mg/kg. assessment the glycemia during CPB.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective CABG EF > 40% Sinus ritmy

Exclusion Criteria:

  • precordialgia emergency surgery combinated surgery not agreement
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): NCT01619436


Locations
Brazil
National institut of Cardiology
Rio de Janeiro, RJ, Brazil, 3600/100
Sponsors and Collaborators
Federal University of Juiz de Fora
More Information

Additional Information:
Responsible Party: Marcello F Salgado Filho, MD, Principal investigator, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT01619436     History of Changes
Other Study ID Numbers: 0279/03.05.2010
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action