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

NCT02714725 | Unknown Phase 4 DMC

• 1 other identifier: N-54-2015
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Sublingual Microcirculation

Keywords

Dexmedetomidine; Microcirculation; On Pump; CABG

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass

• Change in perfused vessel density

  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

  Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass

• Change in Serum lactate

  Immediately before starting CBP (T0) , 30 min after initiation of bypass (T1), and 30 min after weaning from bypass

• Hemodynamic parameters

  Every hour for six hours after induction

Study Arms (2)

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

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

Drug: Dexmedetomidine; Drug: Propofol infusion

Interventions

Dexmedetomidine DRUG

During bypass, patients will receive dexmedetomidine infusion 0.5 mcg/kg/hr

Also known as: Precedex

Group Dexmedetomidine (Group DEX)

Placebo for Dexmedetomidine normal saline infusion DRUG

During bypass, patients will receive normal saline infusion

Also known as: Normal saline infusion

Control group (Group C)

Propofol infusion DRUG

During bypass, patients will receive propofol infusion 50 - 70 mcg/kg/min

Also known as: Diprivan

Control group (Group C); Group Dexmedetomidine (Group DEX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged (\>18), males and females, undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).

You may not qualify if:

• Patient refusal.
• Emergency surgeries
• Redo surgeries
• Pregnancy
• Vasculitis
• Inflammation or infection at the study site
• History of allergic reaction to study medications

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al-Ainy hospitals , Faculty of medicine , Cairo university

Cairo, 11562, Egypt

RECRUITING

Related Publications (16)

• 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.

  PMID: 24161555 BACKGROUND

• Vellinga 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.

  PMID: 20665963 BACKGROUND

• den 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.

  PMID: 20829210 BACKGROUND

• De 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.

  PMID: 19853081 BACKGROUND

• Bauer 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.

  PMID: 18043062 BACKGROUND

• Koning 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.

  PMID: 24035060 BACKGROUND

• De 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.

  PMID: 17845716 BACKGROUND

• Atasever 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.

  PMID: 21115363 BACKGROUND

• Koning 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.

  PMID: 22403352 BACKGROUND

• Yuruk 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.

  PMID: 21133930 BACKGROUND

• Savola 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.

  PMID: 1678707 BACKGROUND

• Gertler 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.

  PMID: 16369581 BACKGROUND

• Miranda 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.

  PMID: 25313879 BACKGROUND

• Yeh 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.

  PMID: 22504209 BACKGROUND

• Boerma 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.

  PMID: 16280059 BACKGROUND

• den Uil CA, Lagrand WK, Spronk PE, van Domburg RT, Hofland J, Luthen C, Brugts JJ, van der Ent M, Simoons ML. Impaired sublingual microvascular perfusion during surgery with cardiopulmonary bypass: a pilot study. J Thorac Cardiovasc Surg. 2008 Jul;136(1):129-34. doi: 10.1016/j.jtcvs.2007.10.046. Epub 2008 May 2.

  PMID: 18603065 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hisham H Abdel Wahab, MD

  Cairo University

  STUDY CHAIR

• Hossam S El-Ashmawi, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Pierre Z Tawadros, MD

  Cairo University

  STUDY CHAIR

• Hassan M Hassan, M.D,FCAI

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hassan M Ahmed, M.D,FCAI

CONTACT

+201009025183; drhassanmohamed@yahoo.com

Hossam S El-Ashmawi, MD

CONTACT

+201001707493; h.elashmawi@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: March 21, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)