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Atrial fibrillation (AF) occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABG) and is associated with numerous detrimental sequelae. In postoperative period, the patient may be exposed to several proarrhythmogenic factors as increased endogenous catecholamines, inflammatory and oxidative mediators secondary to surgical stress and the systemic response to cardiopulmonary bypass, use of inotropic support. Steroids suppress the release of the above-mentioned inflammatory mediators. Dexmedetomidine is sympatholytic, along with anti-inflammatory properties. so combined use of both drugs may have synergistic effect to prevent post operative AF (POAF)
Postoperative atrial fibrillation (POAF) is a common postoperative complication that occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABAG) and is associated with numerous detrimental sequelae.
POAF is an independent predictor of numerous adverse outcomes, including a 2- to 4-fold increased risk of stroke, reoperation for bleeding, infection, renal or respiratory failure, cardiac arrest, cerebral complications, need for permanent pacemaker placement, and a 2-fold increase in all-cause 30-day and 6-month mortality.
Clinical efforts to prevent and manage POAF following cardiac surgery have thus far presented a major challenge and results have been less than optimal. Despite numerous trials examining prophylactic and treatment modalities, POAF incidence following cardiac surgery has not changed over the past several decades.
The pathogenesis of POAF is incompletely understood but likely involves interplay between pre-existing physiological components and local and systemic inflammation. cardiopulmonary bypass and ischemia/reperfusion injury triggers generalized response characterized by leukocyte and complement activation, high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators. These mediators, such as interleukins-6 and -8, tumor necrosis factors, leukotriene B4, and tissue plasminogen activator, might contribute to many postoperative complications including atrial fibrillation (AF).
Because of the known physiologic effects of steroids to suppress the release of the above-mentioned inflammatory mediators, steroids might have beneficial effects in decreasing postoperative AF, and inhibiting the inflammatory process post cardiopulmonary bypass. Moreover, they decrease capillary wall permeability, preventing migration of inflammatory mediators into the systemic circulation. Also, Corticosteroids decrease the heterogeneity of atrial conduction and reduce inflammation following cardiac surgery, and studies have shown that preoperative prophylactic corticosteroids reduced POAF incidence without an increased rate of postoperative infection.
Dexmedetomidine is a very specific intravenously and short-acting alpha-2 agonist which theoretically reduces the sympathetic output by decreasing serum levels of norepinephrine and inhibits the release of cytokines and results in reduction of the incidence of tachycardia, inflammation, high blood pressure during and after surgery. Dexmedetomidine reduces heart rate and consequently improves myocardial oxygen demand. It also depresses sinus node and atrial ventricular nodal function which, along with the drug's anti-inflammatory properties, makes dexmedetomidine a reasonable prophylactic drug for postoperative atrial fibrillation.
So, the investigators that combined use of both drugs will have synergistic effect to prevent (POAF) after (CABG) surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine + Hydrocortisone group | Active Comparator | Patients will receive dexmedetomidine 0.7 ɥg/kg/hr IV infusion before aortic cross-clamping, and will be continued intra-operatively and in ICU till weaning from mechanical ventilation Patients also will also receive Hydrocortisone 100 mg intravenous (IV) before aortic cross-clamping then 100 mg every 8 hours after surgery which will be continued for 48 hours . |
|
| Standard group | No Intervention | Patients will not receive dexmedetomidine nor Hydrocortisone and will receive the standard management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine + Hydrocortisone | Drug | Patients will receive dexmedetomidine 0.7 ɥg/kg/hr IV infusion before aortic cross-clamping, and will be continued intra-operatively and in ICU till weaning from mechanical ventilation Patients also will also receive Hydrocortisone 100 mg intravenous (IV) before aortic cross-clamping then 100 mg every 8 hours after surgery which will be continued for 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of AF | The occurrence of an episode of AF postoperatively | Up to 7 days Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| ICU stay | length of ICU stay in days | Up to 7 days Postoperative |
| Hospital stay | length of hospital stay in days | Up to 10 days Postoperative |
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Inclusion Criteria:
- Scheduled for CABG Surgery with cardiopulmonary bypass (CPB) pump
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic Academy, Ain Shams University Hospitals | Recruiting | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20434173 | Background | Shen J, Lall S, Zheng V, Buckley P, Damiano RJ Jr, Schuessler RB. The persistent problem of new-onset postoperative atrial fibrillation: a single-institution experience over two decades. J Thorac Cardiovasc Surg. 2011 Feb;141(2):559-70. doi: 10.1016/j.jtcvs.2010.03.011. | |
| 28369234 | Background | Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D006854 | Hydrocortisone |
| C007133 | hydrocortisone hemisuccinate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Bradycardia | Occurrence of Bradycardia defined as: HR≤50 bpm | Up to 2 days Postoperative |
| Hypotension | Occurrence of Hypotension defined as decrease in systolic blood pressure >20%of basal | Up to 2 days Postoperative |
| Hyperglycemia | Occurrence of Uncontrolled hyperglycemia Defined as insulin requirement >1 units/kg/day or > 100 units/day of insulin to keep RBS < 180 mg/dL | Up to 7 days Postoperative |
| Wound infection | The occurrence of Wound infection postoperatively | Up to 2 weeks Postoperative |
| 24495440 | Background | Liu C, Wang J, Yiu D, Liu K. The efficacy of glucocorticoids for the prevention of atrial fibrillation, or length of intensive care unite or hospital stay after cardiac surgery: a meta-analysis. Cardiovasc Ther. 2014 Jun;32(3):89-96. doi: 10.1111/1755-5922.12062. |
| 24633361 | Background | Philip I, Berroeta C, Leblanc I. Perioperative challenges of atrial fibrillation. Curr Opin Anaesthesiol. 2014 Jun;27(3):344-52. doi: 10.1097/ACO.0000000000000070. |
| 26060574 | Background | Narisawa A, Nakane M, Kano T, Momose N, Onodera Y, Akimoto R, Kobayashi T, Iwabuchi M, Okada M, Miura Y, Kawamae K. Dexmedetomidine sedation during the nighttime reduced the incidence of postoperative atrial fibrillation in cardiovascular surgery patients after tracheal extubation. J Intensive Care. 2015 May 30;3(1):26. doi: 10.1186/s40560-015-0092-5. eCollection 2015. |
| 26063213 | Background | Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5. |
| 24773263 | Background | Ueki M, Kawasaki T, Habe K, Hamada K, Kawasaki C, Sata T. The effects of dexmedetomidine on inflammatory mediators after cardiopulmonary bypass. Anaesthesia. 2014 Jul;69(7):693-700. doi: 10.1111/anae.12636. Epub 2014 Apr 28. |
| 30703431 | Background | January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available. |
| 34966972 | Background | Leung L, Lee LHN, Lee B, Chau A, Wang EHZ. The safety of high-dose dexmedetomidine after cardiac surgery: a historical cohort study. Can J Anaesth. 2022 Mar;69(3):323-332. doi: 10.1007/s12630-021-02167-z. Epub 2021 Dec 29. |
| 28127215 | Background | Al-Shawabkeh Z, Al-Nawaesah K, Anzeh RA, Al-Odwan H, Al-Rawashdeh WA, Altaani H. Use of short-term steroids in the prophylaxis of atrial fibrillation after cardiac surgery. J Saudi Heart Assoc. 2017 Jan;29(1):23-29. doi: 10.1016/j.jsha.2016.03.005. Epub 2016 Apr 7. |
| 27092020 | Background | Church TJ, Haines ST. Treatment Approach to Patients With Severe Insulin Resistance. Clin Diabetes. 2016 Apr;34(2):97-104. doi: 10.2337/diaclin.34.2.97. |
| 31054241 | Background | Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153. |
| 40289414 | Derived | Alhadidy MA, Alansary AM, Elghareeb SH. Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Clinical Trial. Semin Cardiothorac Vasc Anesth. 2025 Dec;29(4):284-290. doi: 10.1177/10892532251338374. Epub 2025 Apr 27. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |