Sublingual MicrocirculationPhase 4NCT02714725
Effect Of Dexmedetomidine On Sublingual Microcirculation In Patients Undergoing On Pump CABG Surgery
A Phase 4 study testing Dexmedetomidine and Propofol infusion in people with Sublingual Microcirculation, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sublingual Microcirculation
- What is being tested?
- Dexmedetomidine and Propofol infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Aug 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged (>18), males and females, undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Who cannot join
- Patient refusal.
- Emergency surgeries
- Redo surgeries
- Pregnancy
- Vasculitis
- Inflammation or infection at the study site
- History of allergic reaction to study medications
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al-Ainy hospitals , Faculty of medicine , Cairo university
Cairo, 11562
Hassan M Hassan, MD., FCAI, +201009025183, drhassanmohamed@yahoo.com
Hossam S El-Ashmawi, MD
About this study
Official title: Effect Of Dexmedetomidine Infusion On Sublingual Microcirculation In Patients Undergoing On Pump Coronary Artery Bypass Graft Surgery
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
Read the detailed description
All patients will be premedicated the night before surgery with bromazepam 3 mg PO, and 0.1 mg/Kg morphine sulphate IM one hour preoperatively. Upon arrival to the pre-induction room, the patient will receive supplementary oxygen via a nasal cannula, and will be monitored with ECG, Non invasive blood pressure and pulse oximeter. Under local infiltration anesthesia (lidocaine 2%) a peripheral venous cannula (14 or 16 G) and a 20 G arterial cannula will be inserted. Induction of anesthesia will be accomplished with fentanyl (7-10 μg/Kg), propofol 0.5 - 1.0 mg/Kg and pancuronium (0.08 - 0.12 mg/Kg). After intubation a triple lumen central venous catheter will be inserted in a central vein. The temperature probe will be inserted in the nasopharynx; the TEE probe will be also inserted after decompression of the stomach with a nasogastric tube.
All patients will be mechanically ventilated with a tidal volume of 6-8 mL/kg and a respiratory rate of 12 - 14 to achieve end-tidal CO2 30 - 35 mmHg . A PEEP of 5 cm H2O is also added. FiO2 will be adjusted to achieve a PaO2 between 200 and 300 mmHg. Isoflurane will be adjusted to 1 - 1.5 expired MAC , as well as fentanyl increments of 2 μg/Kg will be used to control adequate level of anesthesia and to maintain hemodynamic stability. Incremental doses of pancuronium will be administered as needed.
Before starting CPB anticoagulation with 400IU/kg heparin iv will be administered and activated clotting time (ACT) will be used to check proper anticoagulation throughout CPB aiming at ACT >400s.
Cardiopulmonary bypass flow rate of 2.2 - 2.4 l/min/m2 is maintained aiming to keep MAP of 50-80 mmHg together with the use of vasopressors and vasodilators when needed. After Initiation of CPB mild hypothermia (34-35℃) will be performed . During weaning from CPB, volume and pharmacological therapy with inotropes and vasodilators will be used as needed to maintain hemodynamic stability. All blood on the CPB machine will be re-infused into the patient and protamine will be administered in a dose of 4 mg/kg to return ACT to baseline values.
Using a computer-generated random sequence of numbers, patients will be allocated to one of the following two study groups:
- Control group (Group C): During bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus normal saline infusion
- 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 Patients and investigators performing the study and assessing its outcomes will all be blinded to the study group allocation. The study drugs will be prepared by a separate investigator not involved in either study performance or analysis.
Data collection Microcirculation will be studied with side-stream dark field (SDF) imaging (Microscan; MicroVision Medical, Amsterdam, Netherlands) at three times; Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass (T2) Side stream dark field imaging is equipped with sterile caps to avoid contamination. Briefly, after gentle cleansing by isotonic-saline-drenched gauze, avoiding pressure artefacts, 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 . 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. For each patient, the values from 5 videos will be averaged. In addition, vascular density will be quantified as the number of vessels per millimeters squared. To determine heterogeneity of perfusion, the flow heterogeneity index will be calculated as the highest MFI minus the lowest MFI divided by the mean MFI. Finally, the percent of perfused vessels and the total and capillary perfused vascular densities will be calculated. The percent of perfused vessels will be calculated as the number of vessels with flows 2 and 3 divided by the total number of vessels and multiplied by 100. The perfused vascular density will be calculated as the number of vessels multiplied by the fraction of perfused vessels. These quantifications of flow were made per group of vessel diameter: small (capillaries), 10 to 20 μm; medium, 21 to 50 μm; and large, 51 to 100 μm Sample size (number of participants included) 68 patients (34 in each group) Power analysis was performed using Student's t-test for independent samples with MFI as the primary outcome. A previous study demonstrated that MFI during cardiopulmonary bypass was approximately 2.6 + 1. Sample size was calculated to detect a 25% difference in MFI between the two groups with a power of 0.8 and an alpha error of 0.5. A minimum of 62 patients (31 in each group) would be necessary, and this was increased to 68 (34 in each group) to compensate for dropouts.
Statistical analysis Data will expressed as mean + SD, median (range), or frequency as appropriate. Categorical variables will be compared using Chi-square or Fisher's exact test as appropriate. Normally distributed data will be compared using Student's t-test while non-normally distributed data will be compared using Mann-Whitney test or the Kruskal-Wallis test as appropriate. Intergroup comparisons will be done using analysis of variance with repeated measures and post-hoc Dunnett test. A P-value < 0.05 will be considered statistically significant.
- Conditions
- Sublingual Microcirculation
- Being tested
- Dexmedetomidine, Placebo for Dexmedetomidine normal saline infusion, Propofol infusion
- Keywords
- Dexmedetomidine, Microcirculation, On Pump, CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
During bypass, patients will receive dexmedetomidine infusion 0.5 mcg/kg/hr
Placebo for Dexmedetomidine normal saline infusionDrug
Also called Normal saline infusion
During bypass, patients will receive normal saline infusion
Propofol infusionDrug
Also called Diprivan
During bypass, patients will receive propofol infusion 50 - 70 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group C) | Placebo comparator | During bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus normal saline infusion Receives: Drug: Placebo for Dexmedetomidine normal saline infusion; Drug: Propofol infusion |
| Group Dexmedetomidine (Group DEX) | Active comparator | During bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus dexmedetomidine infusion 0.5 mcg/kg/hr Receives: Drug: Dexmedetomidine; Drug: Propofol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microvascular flow index
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.
Measured: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass
Secondary outcomes (6)
Change in Total vascular density
the number of vessels per millimeters squared
Measured: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass
Change in perfused vessel density
the number of vessels multiplied by the fraction of perfused vessels
Measured: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass
Change in proportion of perfused vessel
the number of vessels with flows 2 and 3 divided by the total number of vessels and multiplied by 100
Measured: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass
Change in Serum lactate
Measured: Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass
Hemodynamic parameters
Mean arterial pressure (MAP)
Measured: Every hour for six hours after induction
Vasopressor dose
Measured: Every hour for six hours after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Sublingual MicrocirculationStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan mohamed, Cairo University
- Investigators
- Hisham H Abdel Wahab, MD, Study chair, Cairo UniversityHossam S El-Ashmawi, MD, Principal investigator, Cairo UniversityPierre Z Tawadros, MD, Study chair, Cairo UniversityHassan M Hassan, M.D,FCAI, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714725
- Sponsor's protocol ID
- N-54-2015
- Status last verified
- Jan 2018
- First submitted
- 13 Mar 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
PubMed 24161555Vellinga NA, Ince C, Boerma EC. Microvascular dysfunction in the surgical patient. Curr Opin Crit Care. 2010 Aug;16(4):377-83. doi: 10.1097/mcc.0b013e32833a0633.
PubMed 20665963den Uil CA, Lagrand WK, van der Ent M, Jewbali LS, Cheng JM, Spronk PE, Simoons ML. Impaired microcirculation predicts poor outcome of patients with acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. 2010 Dec;31(24):3032-9. doi: 10.1093/eurheartj/ehq324. Epub 2010 Sep 9.
PubMed 20829210De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002.
PubMed 19853081Bauer A, Kofler S, Thiel M, Eifert S, Christ F. Monitoring of the sublingual microcirculation in cardiac surgery using orthogonal polarization spectral imaging: preliminary results. Anesthesiology. 2007 Dec;107(6):939-45. doi: 10.1097/01.anes.0000291442.69337.c9.
PubMed 18043062Koning NJ, Atasever B, Vonk AB, Boer C. Changes in microcirculatory perfusion and oxygenation during cardiac surgery with or without cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1331-40. doi: 10.1053/j.jvca.2013.04.009. Epub 2013 Sep 12. No abstract available.
PubMed 24035060De Backer D, Hollenberg S, Boerma C, Goedhart P, Buchele G, Ospina-Tascon G, Dobbe I, Ince C. How to evaluate the microcirculation: report of a round table conference. Crit Care. 2007;11(5):R101. doi: 10.1186/cc6118.
PubMed 17845716Atasever B, Boer C, Goedhart P, Biervliet J, Seyffert J, Speekenbrink R, Schwarte L, de Mol B, Ince C. Distinct alterations in sublingual microcirculatory blood flow and hemoglobin oxygenation in on-pump and off-pump coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):784-90. doi: 10.1053/j.jvca.2010.09.002. Epub 2010 Nov 5.
PubMed 21115363Koning NJ, Vonk AB, van Barneveld LJ, Beishuizen A, Atasever B, van den Brom CE, Boer C. Pulsatile flow during cardiopulmonary bypass preserves postoperative microcirculatory perfusion irrespective of systemic hemodynamics. J Appl Physiol (1985). 2012 May;112(10):1727-34. doi: 10.1152/japplphysiol.01191.2011. Epub 2012 Mar 8.
PubMed 22403352Yuruk K, Almac E, Bezemer R, Goedhart P, de Mol B, Ince C. Blood transfusions recruit the microcirculation during cardiac surgery. Transfusion. 2011 May;51(5):961-7. doi: 10.1111/j.1537-2995.2010.02971.x. Epub 2010 Dec 6.
PubMed 21133930Savola JM, Virtanen R. Central alpha 2-adrenoceptors are highly stereoselective for dexmedetomidine, the dextro enantiomer of medetomidine. Eur J Pharmacol. 1991 Mar 26;195(2):193-9. doi: 10.1016/0014-2999(91)90535-x.
PubMed 1678707Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
PubMed 16369581Miranda ML, Balarini MM, Bouskela E. Dexmedetomidine attenuates the microcirculatory derangements evoked by experimental sepsis. Anesthesiology. 2015 Mar;122(3):619-30. doi: 10.1097/ALN.0000000000000491.
PubMed 25313879Yeh YC, Sun WZ, Ko WJ, Chan WS, Fan SZ, Tsai JC, Lin TY. Dexmedetomidine prevents alterations of intestinal microcirculation that are induced by surgical stress and pain in a novel rat model. Anesth Analg. 2012 Jul;115(1):46-53. doi: 10.1213/ANE.0b013e318253631c. Epub 2012 Apr 13.
PubMed 22504209Boerma EC, Mathura KR, van der Voort PH, Spronk PE, Ince C. Quantifying bedside-derived imaging of microcirculatory abnormalities in septic patients: a prospective validation study. Crit Care. 2005;9(6):R601-6. doi: 10.1186/cc3809. Epub 2005 Sep 22.
PubMed 16280059
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Dexmedetomidine Infusion On Sublingual Microcirculation In Patients Undergoing On Pump Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT02714725
- Acronym / sponsor ID
- N-54-2015
- Conditions
- Sublingual Microcirculation
- Keywords
- Dexmedetomidine, Microcirculation, On Pump, CABG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 Mar 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.
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
Detailed description
All patients will be premedicated the night before surgery with bromazepam 3 mg PO, and 0.1 mg/Kg morphine sulphate IM one hour preoperatively. Upon arrival to the pre-induction room, the patient will receive supplementary oxygen via a nasal cannula, and will be monitored with ECG, Non invasive blood pressure and pulse oximeter. Under local infiltration anesthesia (lidocaine 2%) a peripheral venous cannula (14 or 16 G) and a 20 G arterial cannula will be inserted. Induction of anesthesia will be accomplished with fentanyl (7-10 μg/Kg), propofol 0.5 - 1.0 mg/Kg and pancuronium (0.08 - 0.12 mg/Kg). After intubation a triple lumen central venous catheter will be inserted in a central vein. The temperature probe will be inserted in the nasopharynx; the TEE probe will be also inserted after decompression of the stomach with a nasogastric tube.
All patients will be mechanically ventilated with a tidal volume of 6-8 mL/kg and a respiratory rate of 12 - 14 to achieve end-tidal CO2 30 - 35 mmHg . A PEEP of 5 cm H2O is also added. FiO2 will be adjusted to achieve a PaO2 between 200 and 300 mmHg. Isoflurane will be adjusted to 1 - 1.5 expired MAC , as well as fentanyl increments of 2 μg/Kg will be used to control adequate level of anesthesia and to maintain hemodynamic stability. Incremental doses of pancuronium will be administered as needed.
Before starting CPB anticoagulation with 400IU/kg heparin iv will be administered and activated clotting time (ACT) will be used to check proper anticoagulation throughout CPB aiming at ACT >400s.
Cardiopulmonary bypass flow rate of 2.2 - 2.4 l/min/m2 is maintained aiming to keep MAP of 50-80 mmHg together with the use of vasopressors and vasodilators when needed. After Initiation of CPB mild hypothermia (34-35℃) will be performed . During weaning from CPB, volume and pharmacological therapy with inotropes and vasodilators will be used as needed to maintain hemodynamic stability. All blood on the CPB machine will be re-infused into the patient and protamine will be administered in a dose of 4 mg/kg to return ACT to baseline values.
Using a computer-generated random sequence of numbers, patients will be allocated to one of the following two study groups:
- Control group (Group C): During bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus normal saline infusion
- 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 Patients and investigators performing the study and assessing its outcomes will all be blinded to the study group allocation. The study drugs will be prepared by a separate investigator not involved in either study performance or analysis.
Data collection Microcirculation will be studied with side-stream dark field (SDF) imaging (Microscan; MicroVision Medical, Amsterdam, Netherlands) at three times; Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass (T2) Side stream dark field imaging is equipped with sterile caps to avoid contamination. Briefly, after gentle cleansing by isotonic-saline-drenched gauze, avoiding pressure artefacts, 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 . 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. For each patient, the values from 5 videos will be averaged. In addition, vascular density will be quantified as the number of vessels per millimeters squared. To determine heterogeneity of perfusion, the flow heterogeneity index will be calculated as the highest MFI minus the lowest MFI divided by the mean MFI. Finally, the percent of perfused vessels and the total and capillary perfused vascular densities will be calculated. The percent of perfused vessels will be calculated as the number of vessels with flows 2 and 3 divided by the total number of vessels and multiplied by 100. The perfused vascular density will be calculated as the number of vessels multiplied by the fraction of perfused vessels. These quantifications of flow were made per group of vessel diameter: small (capillaries), 10 to 20 μm; medium, 21 to 50 μm; and large, 51 to 100 μm Sample size (number of participants included) 68 patients (34 in each group) Power analysis was performed using Student's t-test for independent samples with MFI as the primary outcome. A previous study demonstrated that MFI during cardiopulmonary bypass was approximately 2.6 + 1. Sample size was calculated to detect a 25% difference in MFI between the two groups with a power of 0.8 and an alpha error of 0.5. A minimum of 62 patients (31 in each group) would be necessary, and this was increased to 68 (34 in each group) to compensate for dropouts.
Statistical analysis Data will expressed as mean + SD, median (range), or frequency as appropriate. Categorical variables will be compared using Chi-square or Fisher's exact test as appropriate. Normally distributed data will be compared using Student's t-test while non-normally distributed data will be compared using Mann-Whitney test or the Kruskal-Wallis test as appropriate. Intergroup comparisons will be done using analysis of variance with repeated measures and post-hoc Dunnett test. A P-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Group C) | Placebo comparator | Drug: Placebo for Dexmedetomidine normal saline infusion, Drug: Propofol infusionDuring bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus normal saline infusion |
| Group Dexmedetomidine (Group DEX) | Active comparator | Drug: Dexmedetomidine, Drug: Propofol infusionDuring bypass, patients in this group will receive propofol infusion 50 - 70 mcg/kg/min plus dexmedetomidine infusion 0.5 mcg/kg/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged (>18), males and females, undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Key exclusion criteria (7 listed)
- Patient refusal.
- Emergency surgeries
- Redo surgeries
- Pregnancy
- Vasculitis
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: PrecedexDuring bypass, patients will receive dexmedetomidine infusion 0.5 mcg/kg/hr | Drug | Group Dexmedetomidine (Group DEX) |
| Placebo for Dexmedetomidine normal saline infusionAlso: Normal saline infusionDuring bypass, patients will receive normal saline infusion | Drug | Control group (Group C) |
| Propofol infusionAlso: DiprivanDuring bypass, patients will receive propofol infusion 50 - 70 mcg/kg/min | Drug | Control group (Group C), Group Dexmedetomidine (Group DEX) |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
Hemodynamic parameters
Time frame: Every hour for six hours after induction
Vasopressor dose
Time frame: Every hour for six hours after induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Background: PubMed 24161555Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
- Background: PubMed 20665963Vellinga NA, Ince C, Boerma EC. Microvascular dysfunction in the surgical patient. Curr Opin Crit Care. 2010 Aug;16(4):377-83. doi: 10.1097/mcc.0b013e32833a0633.
- Background: PubMed 20829210den Uil CA, Lagrand WK, van der Ent M, Jewbali LS, Cheng JM, Spronk PE, Simoons ML. Impaired microcirculation predicts poor outcome of patients with acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. 2010 Dec;31(24):3032-9. doi: 10.1093/eurheartj/ehq324. Epub 2010 Sep 9.
- Background: PubMed 19853081De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002.
- Background: PubMed 18043062Bauer A, Kofler S, Thiel M, Eifert S, Christ F. Monitoring of the sublingual microcirculation in cardiac surgery using orthogonal polarization spectral imaging: preliminary results. Anesthesiology. 2007 Dec;107(6):939-45. doi: 10.1097/01.anes.0000291442.69337.c9.
- Background: PubMed 24035060Koning NJ, Atasever B, Vonk AB, Boer C. Changes in microcirculatory perfusion and oxygenation during cardiac surgery with or without cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1331-40. doi: 10.1053/j.jvca.2013.04.009. Epub 2013 Sep 12. No abstract available.
- Background: PubMed 17845716De Backer D, Hollenberg S, Boerma C, Goedhart P, Buchele G, Ospina-Tascon G, Dobbe I, Ince C. How to evaluate the microcirculation: report of a round table conference. Crit Care. 2007;11(5):R101. doi: 10.1186/cc6118.
- Background: PubMed 21115363Atasever B, Boer C, Goedhart P, Biervliet J, Seyffert J, Speekenbrink R, Schwarte L, de Mol B, Ince C. Distinct alterations in sublingual microcirculatory blood flow and hemoglobin oxygenation in on-pump and off-pump coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):784-90. doi: 10.1053/j.jvca.2010.09.002. Epub 2010 Nov 5.
- Background: PubMed 22403352Koning NJ, Vonk AB, van Barneveld LJ, Beishuizen A, Atasever B, van den Brom CE, Boer C. Pulsatile flow during cardiopulmonary bypass preserves postoperative microcirculatory perfusion irrespective of systemic hemodynamics. J Appl Physiol (1985). 2012 May;112(10):1727-34. doi: 10.1152/japplphysiol.01191.2011. Epub 2012 Mar 8.
- Background: PubMed 21133930Yuruk K, Almac E, Bezemer R, Goedhart P, de Mol B, Ince C. Blood transfusions recruit the microcirculation during cardiac surgery. Transfusion. 2011 May;51(5):961-7. doi: 10.1111/j.1537-2995.2010.02971.x. Epub 2010 Dec 6.
- Background: PubMed 1678707Savola JM, Virtanen R. Central alpha 2-adrenoceptors are highly stereoselective for dexmedetomidine, the dextro enantiomer of medetomidine. Eur J Pharmacol. 1991 Mar 26;195(2):193-9. doi: 10.1016/0014-2999(91)90535-x.
- Background: PubMed 16369581Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
- Individual participant dataSharing planned: No
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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.
Hisham H Abdel Wahab, MD study chair
Cairo University
Hossam S El-Ashmawi, MD principal investigator
Cairo University
Pierre Z Tawadros, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Propofol infusion in people with Sublingual Microcirculation, run by Cairo 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 7 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: status not confirmed, as of the sponsor's last update on 24 Jan 2018. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan M Ahmed, M.D,FCAI (+201009025183, drhassanmohamed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02714725, which also lists 16 linked publications.
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 24 Jan 2018.