- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02727621
Dexmedetomidine Sedation and Cardiopulmonary Bypass
September 25, 2016 updated by: Sayed Kaoud Abd-Elshafy, Assiut University
Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study
Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the depth of sedation and provides analgesia, cardio protection, renal protection, and neuroprotection without causing respiratory depression.
It is an alpha 2-adrenoreceptor agonist that modulates the release of catecholamines from the central and autonomic nervous systems.
When patients sedated by dexmedetomidine are allowed to become responsive, they are calm and cooperative (1).
No other sedative agent has this feature, and sedated patients frequently awaken in a confused state.
Investigators are conducting this study project to compare between dexmedetomidine based and propofol based anesthetic techniques with regard to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB for coronary revascularization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
100 patients undergoing elective CPB for coronary revascularization surgery.
On the morning of operation the patients were randomized to receive one of two anesthetic techniques dependent on the type of sedation used.
Standard anesthetic technique will be used for all patients except for using dexmedetomidine sedation in one group and propofol sedation in the other group.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass
Exclusion Criteria:
- Severely impaired left ventricular function (ejection fraction <40%)
- Valvular heart disease
- Low cardiac output syndrome
- Uncontrolled rapid atrial fibrillation
- On plavix less than one week
- Severe systemic non-cardiac disease
- Infectious disease
- Poorly controlled diabetes mellitus
- patients on corticosteroids or other immunosuppressive treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propofol group
|
Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values.
Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.
Other Names:
|
Active Comparator: Dexmedetomidine group
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Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values.
Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac index
Time Frame: within intraoperative period
|
cardiac index measured in L/min/m2
|
within intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate
Time Frame: within intraoperative period
|
heart rate measured in beat/min.
|
within intraoperative period
|
mean arterial blood pressure
Time Frame: within intraoperative period
|
mean arterial blood pressure measured in mm.Hg
|
within intraoperative period
|
central venous pressure
Time Frame: within intraoperative period
|
central venous pressure measured in mm.Hg
|
within intraoperative period
|
pulmonary capillary wedge pressure
Time Frame: within intraoperative period
|
pulmonary capillary wedge pressure measured in mm.Hg
|
within intraoperative period
|
mean pulmonary artery pressure
Time Frame: within intraoperative period
|
mean pulmonary artery pressure measure in mm.Hg
|
within intraoperative period
|
systemic vascular resistance index
Time Frame: within intraoperative period
|
systemic vascular resistance index measured in dyn.sec/cm5/m2
|
within intraoperative period
|
pulmonary vascular resistance index
Time Frame: within intraoperative period
|
pulmonary vascular resistance index measured in dyn.sec/cm5/m2
|
within intraoperative period
|
stroke volume index
Time Frame: within intraoperative period
|
stroke volume index measured in ml/m2/beat
|
within intraoperative period
|
left ventricular stroke work index
Time Frame: within intraoperative period
|
left ventricular stroke work index measured in gm/m2/beat
|
within intraoperative period
|
cardiac output
Time Frame: within intraoperative period
|
cardiac output measured in L/min
|
within intraoperative period
|
inotrope score
Time Frame: 1st 24 hours
|
appropriate score
|
1st 24 hours
|
duration of mechanical ventilation
Time Frame: 1st week
|
duration of mechanical ventilation measured in hours
|
1st week
|
sedation score
Time Frame: 1st 24 hours
|
appropriate score
|
1st 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sayed Abd-Elshafy, MD, Associate professor, anesthesia and critical care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
March 30, 2016
First Submitted That Met QC Criteria
April 1, 2016
First Posted (Estimate)
April 4, 2016
Study Record Updates
Last Update Posted (Estimate)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 25, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- IRB000087801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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