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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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12 December 2020 |
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Main ID: |
NCT02714725 |
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Date of registration:
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13/03/2016 |
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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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Effect Of Dexmedetomidine On Sublingual Microcirculation In Patients Undergoing On Pump CABG Surgery
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Scientific title:
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Effect Of Dexmedetomidine Infusion On Sublingual Microcirculation In Patients Undergoing On Pump Coronary Artery Bypass Graft Surgery |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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70 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02714725 |
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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. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Pierre Z Tawadros, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Hisham H Abdel Wahab, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Hossam S El-Ashmawi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Hassan M Ahmed, M.D,FCAI |
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Address:
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Telephone:
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+201009025183 |
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Email:
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drhassanmohamed@yahoo.com |
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Affiliation:
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Name:
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Hassan M Hassan, MD., FCAI |
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Address:
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Telephone:
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+201009025183 |
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Email:
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drhassanmohamed@yahoo.com |
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Affiliation:
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Name:
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Hassan M Hassan, M.D,FCAI |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients aged (>18), males and females, undergoing elective coronary artery
bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Exclusion Criteria:
- Patient refusal.
- Emergency surgeries
- Redo surgeries
- Pregnancy
- Vasculitis
- Inflammation or infection at the study site
- History of allergic reaction to study medications
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sublingual Microcirculation
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Placebo for Dexmedetomidine normal saline infusion
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Drug: Propofol infusion
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Primary Outcome(s)
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Change in Microvascular flow index
[Time Frame: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass]
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Secondary Outcome(s)
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Change in Serum lactate
[Time Frame: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass]
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Change in perfused vessel density
[Time Frame: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass]
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Change in Total vascular density
[Time Frame: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass]
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Change in proportion of perfused vessel
[Time Frame: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass]
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Hemodynamic parameters
[Time Frame: Every hour for six hours after induction]
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Vasopressor dose
[Time Frame: Every hour for six hours after induction]
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Secondary ID(s)
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N-54-2015
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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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