NCT02407626

Brief Summary

This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

March 18, 2015

Last Update Submit

March 8, 2018

Conditions

Myocardial Ischemia

Keywords

ischemiacardiac surgeryvolatile anesthetictotal intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

  • Biomarker NT-proBNP

    Difference between volatile anesthesia and total intravenous anesthesia

    1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3

Secondary Outcomes (2)

  • Receptor Substrate phosphorylization (IRS-1)/PP2A

    1. beginning of cardiac surgery, 2. end of cardiac surgery

  • Expression of TNF/IL1beta and microRNA (miR144, miR125b, miR208a)

    1. beginning of cardiac surgery, 2. end of cardiac surgery

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Volatile anesthesia for elective cardiac surgery

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

Total intravenous anesthesia for elective cardiac surgery

Drug: Propofol

Interventions

PropofolDRUG

Total intravenous anesthesia is a clinical standard procedure

Propofol
SevofluraneDRUG

Volatile anesthesia is a clinical standard procedure

Sevoflurane

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes
  • Elective cardiac surgery

You may not qualify if:

  • Emergency procedures
  • Preop myocardial infarction
  • Preop cardiac failure
  • Preop renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Triemli City Hospital

Zurich, 8063, Switzerland

Location

Related Publications (10)

  • Julier K, da Silva R, Garcia C, Bestmann L, Frascarolo P, Zollinger A, Chassot PG, Schmid ER, Turina MI, von Segesser LK, Pasch T, Spahn DR, Zaugg M. Preconditioning by sevoflurane decreases biochemical markers for myocardial and renal dysfunction in coronary artery bypass graft surgery: a double-blinded, placebo-controlled, multicenter study. Anesthesiology. 2003 Jun;98(6):1315-27. doi: 10.1097/00000542-200306000-00004.

    PMID: 12766638BACKGROUND

  • Lucchinetti E, Hofer C, Bestmann L, Hersberger M, Feng J, Zhu M, Furrer L, Schaub MC, Tavakoli R, Genoni M, Zollinger A, Zaugg M. Gene regulatory control of myocardial energy metabolism predicts postoperative cardiac function in patients undergoing off-pump coronary artery bypass graft surgery: inhalational versus intravenous anesthetics. Anesthesiology. 2007 Mar;106(3):444-57. doi: 10.1097/00000542-200703000-00008.

    PMID: 17325502BACKGROUND

  • Piriou V, Mantz J, Goldfarb G, Kitakaze M, Chiari P, Paquin S, Cornu C, Lecharny JB, Aussage P, Vicaut E, Pons A, Lehot JJ. Sevoflurane preconditioning at 1 MAC only provides limited protection in patients undergoing coronary artery bypass surgery: a randomized bi-centre trial. Br J Anaesth. 2007 Nov;99(5):624-31. doi: 10.1093/bja/aem264. Epub 2007 Oct 3.

    PMID: 17913754BACKGROUND

  • Zaugg M, Lucchinetti E, Uecker M, Pasch T, Schaub MC. Anaesthetics and cardiac preconditioning. Part I. Signalling and cytoprotective mechanisms. Br J Anaesth. 2003 Oct;91(4):551-65. doi: 10.1093/bja/aeg205.

    PMID: 14504159BACKGROUND

  • Zaugg M, Lucchinetti E, Garcia C, Pasch T, Spahn DR, Schaub MC. Anaesthetics and cardiac preconditioning. Part II. Clinical implications. Br J Anaesth. 2003 Oct;91(4):566-76. doi: 10.1093/bja/aeg206.

    PMID: 14504160BACKGROUND

  • Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.

    PMID: 17707752BACKGROUND

  • Lou PH, Lucchinetti E, Zhang L, Affolter A, Gandhi M, Zhakupova A, Hersberger M, Hornemann T, Clanachan AS, Zaugg M. Propofol (Diprivan(R)) and Intralipid(R) exacerbate insulin resistance in type-2 diabetic hearts by impairing GLUT4 trafficking. Anesth Analg. 2015 Feb;120(2):329-40. doi: 10.1213/ANE.0000000000000558.

    PMID: 25437926BACKGROUND

  • Whittington RA, Virag L, Marcouiller F, Papon MA, El Khoury NB, Julien C, Morin F, Emala CW, Planel E. Propofol directly increases tau phosphorylation. PLoS One. 2011 Jan 31;6(1):e16648. doi: 10.1371/journal.pone.0016648.

    PMID: 21304998BACKGROUND

  • Swart MJ, De Jager WH, Kemp JT, Nel PJ, Van Staden SL, Joubert G. The effect of the metabolic syndrome on the risk and outcome of coronary artery bypass graft surgery. Cardiovasc J Afr. 2012 Aug;23(7):400-4. doi: 10.5830/CVJA-2012-055.

    PMID: 22914999BACKGROUND

  • Wang L, Ko KW, Lucchinetti E, Zhang L, Troxler H, Hersberger M, Omar MA, Posse de Chaves EI, Lopaschuk GD, Clanachan AS, Zaugg M. Metabolic profiling of hearts exposed to sevoflurane and propofol reveals distinct regulation of fatty acid and glucose oxidation: CD36 and pyruvate dehydrogenase as key regulators in anesthetic-induced fuel shift. Anesthesiology. 2010 Sep;113(3):541-51. doi: 10.1097/ALN.0b013e3181e2c1a1.

    PMID: 20683255BACKGROUND

MeSH Terms

Conditions

Myocardial IschemiaIschemia

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Andreas Zollinger, MD

    Institute of Anesthesiology and Intensive Care Medicine Triemli City Hospital Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 3, 2015

Study Start

September 1, 2015

Primary Completion

March 7, 2018

Study Completion

March 7, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)