NCT00821262

Brief Summary

Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane. The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

January 12, 2009

Last Update Submit

October 13, 2015

Conditions

AnesthesiaCardiac Surgery

Keywords

SevofluraneAnesthesiaTroponinMyocardial PreconditioningSurgery, CardiacStentsNon-cardiac SurgerySurgery

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay

Secondary Outcomes (4)

  • cardiac troponin release

  • incidence of perioperative myocardial infarction

  • time on mechanical ventilation

  • postoperative hospital stay

Study Arms (2)

sevoflurane

EXPERIMENTAL

The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).

Drug: sevoflurane

propofol

ACTIVE COMPARATOR

The control group will receive propofol for the same 4-6 hours period.

Drug: propofol

Interventions

sevofluraneDRUG
sevoflurane
propofolDRUG
propofol

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 years
  • written informed consent
  • scheduled procedures

You may not qualify if:

  • ongoing acute myocardial infarction
  • cardiac troponin \>1 ng/ml
  • previous unusual response to an anesthetic
  • use of sulfonylurea, theophylline or allopurinol
  • thoracotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Vita-Salute University

Milan, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)

Perugia, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Location

Università La Sapienza, Policlinico Umberto I, Roma

Roma, Italy

Location

Related Publications (10)

  • Landoni G, Biondi-Zoccai GG, Zangrillo A, Bignami E, D'Avolio S, Marchetti C, Calabro MG, Fochi O, Guarracino F, Tritapepe L, De Hert S, Torri G. Desflurane and sevoflurane in cardiac surgery: a meta-analysis of randomized clinical trials. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):502-11. doi: 10.1053/j.jvca.2007.02.013. Epub 2007 May 7.

    PMID: 17678775BACKGROUND

  • Landoni G, Fochi O, Tritapepe L, Guarracino F, Belloni I, Bignami E, Zangrillo A. Cardiac protection by volatile anesthetics. A review. Minerva Anestesiol. 2009 May;75(5):269-73. Epub 2008 Nov 6.

    PMID: 18987572BACKGROUND

  • Landoni G, Zangrillo A, Fochi O, Maj G, Scandroglio AM, Morelli A, Tritapepe L, Montorfano M, Colombo A. Cardiac protection with volatile anesthetics in stenting procedures. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):543-7. doi: 10.1053/j.jvca.2008.02.020. Epub 2008 May 14.

    PMID: 18662628BACKGROUND

  • Landoni G, Fochi O, Zangrillo A. Cardioprotection by volatile anesthetics in noncardiac surgery? No, not yet at least. J Am Coll Cardiol. 2008 Apr 1;51(13):1321; author reply 1321-2. doi: 10.1016/j.jacc.2007.12.020. No abstract available.

    PMID: 18371566BACKGROUND

  • Landoni G, Calabro MG, Marchetti C, Bignami E, Scandroglio AM, Dedola E, De Luca M, Tritapepe L, Crescenzi G, Zangrillo A. Desflurane versus propofol in patients undergoing mitral valve surgery. J Cardiothorac Vasc Anesth. 2007 Oct;21(5):672-7. doi: 10.1053/j.jvca.2006.11.017. Epub 2007 Feb 22.

    PMID: 17905272BACKGROUND

  • Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabro MG, Zangrillo A. Cardiac protection by volatile anaesthetics: a multicentre randomized controlled study in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. Eur J Anaesthesiol. 2007 Apr;24(4):323-31. doi: 10.1017/S0265021506001931. Epub 2006 Dec 8.

    PMID: 17156509BACKGROUND

  • Guarracino F, Landoni G, Tritapepe L, Pompei F, Leoni A, Aletti G, Scandroglio AM, Maselli D, De Luca M, Marchetti C, Crescenzi G, Zangrillo A. Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):477-83. doi: 10.1053/j.jvca.2006.05.012.

    PMID: 16884976BACKGROUND

  • Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.

    PMID: 19538174BACKGROUND

  • Bignami E, Biondi-Zoccai G, Landoni G, Fochi O, Testa V, Sheiban I, Giunta F, Zangrillo A. Volatile anesthetics reduce mortality in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):594-9. doi: 10.1053/j.jvca.2009.01.022. Epub 2009 Mar 19.

    PMID: 19303327BACKGROUND

  • Landoni G, Guarracino F, Cariello C, Franco A, Baldassarri R, Borghi G, Covello RD, Gerli C, Crivellari M, Zangrillo A. Volatile compared with total intravenous anaesthesia in patients undergoing high-risk cardiac surgery: a randomized multicentre study. Br J Anaesth. 2014 Dec;113(6):955-63. doi: 10.1093/bja/aeu290. Epub 2014 Sep 3.

    PMID: 25186820DERIVED

Related Links

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • giovanni landoni, MD

    Vita-Salute University of Milano. Italy

    PRINCIPAL INVESTIGATOR

  • elena bignami, MD

    Vita-Salute University of Milano, Italy

    STUDY DIRECTOR

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
DM

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

IT(5)