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Effect Of Dexmedetomidine On Sublingual Microcirculation In Patients Undergoing On Pump CABG Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714725
Recruitment Status : Unknown
Verified January 2018 by Hassan mohamed, Cairo University.
Recruitment status was:  Recruiting
First Posted : March 21, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hassan mohamed, Cairo University

Brief Summary:
This study is designed to explore the possible effects of dexmedetomidine infusion on sublingual microcirculation in patients undergoing on-pump coronary artery bypass graft surgery

Condition or disease Intervention/treatment Phase
Sublingual Microcirculation Drug: Dexmedetomidine Drug: Placebo for Dexmedetomidine normal saline infusion Drug: Propofol infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect Of Dexmedetomidine Infusion On Sublingual Microcirculation In Patients Undergoing On Pump Coronary Artery Bypass Graft Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group (Group C)
During bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus normal saline infusion
Drug: Placebo for Dexmedetomidine normal saline infusion
During bypass, patients will receive normal saline infusion
Other Name: Normal saline infusion

Drug: Propofol infusion
During bypass, patients will receive propofol infusion 50 - 70 mcg/kg/min
Other Name: Diprivan

Active Comparator: Group Dexmedetomidine (Group DEX)
During bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus dexmedetomidine infusion 0.5 mcg/kg/hr
Drug: Dexmedetomidine
During bypass, patients will receive dexmedetomidine infusion 0.5 mcg/kg/hr
Other Name: Precedex

Drug: Propofol infusion
During bypass, patients will receive propofol infusion 50 - 70 mcg/kg/min
Other Name: Diprivan




Primary Outcome Measures :
  1. 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 ]
    Microcirculation will be studied with side-stream dark field (SDF) imaging (Microscan; MicroVision Medical, Amsterdam, Netherlands) 5 steady images of at least 20 seconds each will be obtained and stored under a random number. Offline blind analysis of each video will be done by two investigators. A previously validated semiquantitative score will be used (15). It distinguishes between no flow (0), intermittent flow (1), sluggish flow (2), and continuous flow (3). A value is assigned to each individual vessel. The overall score, called the microvascular flow index (MFI), is the average of the individual values.


Secondary Outcome Measures :
  1. 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 ]
    the number of vessels per millimeters squared

  2. 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 ]
    the number of vessels multiplied by the fraction of perfused vessels

  3. 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 ]
    the number of vessels with flows 2 and 3 divided by the total number of vessels and multiplied by 100

  4. 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 ]
  5. Hemodynamic parameters [ Time Frame: Every hour for six hours after induction ]
    Mean arterial pressure (MAP)

  6. Vasopressor dose [ Time Frame: Every hour for six hours after induction ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02714725


Contacts
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Contact: Hassan M Ahmed, M.D,FCAI +201009025183 drhassanmohamed@yahoo.com
Contact: Hossam S El-Ashmawi, MD +201001707493 h.elashmawi@kasralainy.edu.eg

Locations
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Egypt
Kasr Al-Ainy hospitals , Faculty of medicine , Cairo university Recruiting
Cairo, Egypt, 11562
Contact: Hassan M Hassan, MD., FCAI    +201009025183    drhassanmohamed@yahoo.com   
Principal Investigator: Hossam S El-Ashmawi, MD         
Sub-Investigator: Hassan M Hassan, MD., FCAI         
Sub-Investigator: Hisham H Abdel Wahab, MD         
Sub-Investigator: Pierre Z Tawadros, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Hisham H Abdel Wahab, MD Cairo University
Principal Investigator: Hossam S El-Ashmawi, MD Cairo University
Study Chair: Pierre Z Tawadros, MD Cairo University
Study Director: Hassan M Hassan, M.D,FCAI Cairo University
Publications:

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Responsible Party: Hassan mohamed, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT02714725    
Other Study ID Numbers: N-54-2015
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hassan mohamed, Cairo University:
Dexmedetomidine
Microcirculation
On Pump
CABG
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action