Coronary Artery Bypass GraftingPhase 2NCT02727621
Dexmedetomidine Sedation and Cardiopulmonary Bypass
A Phase 2 study testing Dexmedetomidine and propofol in people with Coronary Artery Bypass Grafting, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- Dexmedetomidine and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass
Who cannot join
- 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
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- Infectious disease
- Poorly controlled diabetes mellitus
- patients on corticosteroids or other immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- Dexmedetomidine, propofol
- Keywords
- Dexmedetomidine, Cardiac, Coronary Artery Bypass Grapht, Sedation, Propofol, Intravenous Anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
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.
propofolDrug
Also called diprivan
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Propofol group | Active comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index
cardiac index measured in L/min/m2
Measured: within intraoperative period
Secondary outcomes (13)
heart rate
heart rate measured in beat/min.
Measured: within intraoperative period
mean arterial blood pressure
mean arterial blood pressure measured in mm.Hg
Measured: within intraoperative period
central venous pressure
central venous pressure measured in mm.Hg
Measured: within intraoperative period
pulmonary capillary wedge pressure
pulmonary capillary wedge pressure measured in mm.Hg
Measured: within intraoperative period
mean pulmonary artery pressure
mean pulmonary artery pressure measure in mm.Hg
Measured: within intraoperative period
systemic vascular resistance index
systemic vascular resistance index measured in dyn.sec/cm5/m2
Measured: within intraoperative period
pulmonary vascular resistance index
pulmonary vascular resistance index measured in dyn.sec/cm5/m2
Measured: within intraoperative period
stroke volume index
stroke volume index measured in ml/m2/beat
Measured: within intraoperative period
left ventricular stroke work index
left ventricular stroke work index measured in gm/m2/beat
Measured: within intraoperative period
cardiac output
cardiac output measured in L/min
Measured: within intraoperative period
inotrope score
appropriate score
Measured: 1st 24 hours
duration of mechanical ventilation
duration of mechanical ventilation measured in hours
Measured: 1st week
sedation score
appropriate score
Measured: 1st 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed Abd-Elshafy, MD, Principal investigator, Associate professor, anesthesia and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727621
- Sponsor's protocol ID
- IRB000087801
- Status last verified
- Sep 2016
- First submitted
- 30 Mar 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT02727621
- Acronym / sponsor ID
- IRB000087801
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- Dexmedetomidine, Cardiac, Coronary Artery Bypass Grapht, Sedation, Propofol, Intravenous Anesthetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidine |
| Propofol group | Active comparator | Drug: propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: precedexAnesthesia 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. | Drug | Dexmedetomidine group |
| propofolAlso: diprivanAnesthesia 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. | Drug | Propofol group |
Primary outcome
cardiac index
Time frame: within intraoperative period
cardiac index measured in L/min/m2
13 secondary outcomes
heart rate
Time frame: within intraoperative period
mean arterial blood pressure
Time frame: within intraoperative period
central venous pressure
Time frame: within intraoperative period
pulmonary capillary wedge pressure
Time frame: within intraoperative period
mean pulmonary artery pressure
Time frame: within intraoperative period
systemic vascular resistance index
Time frame: within intraoperative period
pulmonary vascular resistance index
Time frame: within intraoperative period
stroke volume index
Time frame: within intraoperative period
left ventricular stroke work index
Time frame: within intraoperative period
cardiac output
Time frame: within intraoperative period
inotrope score
Time frame: 1st 24 hours
duration of mechanical ventilation
Time frame: 1st week
sedation score
Time frame: 1st 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayed Abd-Elshafy, MD principal investigator
Associate professor, anesthesia and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine and propofol in people with Coronary Artery Bypass Grafting, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac index (time frame: within intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.