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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02405689 |
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Date of registration:
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18/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Myocardial Protection and Anesthetic Agents
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Scientific title:
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The Effect of Sevoflurane-dexmedetomidine and Sevoflurane-remifentanil on Biochemical Markers During Open Heart Surgery |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02405689 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Scheduled to open heart surgery
- American Society of Anesthesiologists (ASA) physical status of II-III
Exclusion Criteria:
- Emergency surgery, prior cardiac surgery, ejection fraction < 50%, restrictive or
obstructive pulmonary disease, preoperative mechanical ventilation, intra-aortic
balloon pump, chronic liver and renal failure.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Ischemic Reperfusion Injury
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Remifentanil
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Drug: Sevoflurane
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Primary Outcome(s)
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level of CKMB
[Time Frame: at 20 minutes after cross clamp, 20 minutes after removal cross clamp, 10 minutes after cardiopulmonary bypass]
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level of laktat
[Time Frame: at 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass]
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level of Troponin-T
[Time Frame: at 20 minutes after cross clamp, 20 minutes after removal cross clamp, 10 minutes after cardiopulmonary bypass]
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Level of pyruvate
[Time Frame: at 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass]
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Secondary ID(s)
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open heart surgery
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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