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CompletedNCT00364637Updated Feb 4, 2025

Volatile Anesthetics in Cardiac Protection

A Phase 4 interventional study of Sevoflurane (Volatile Anesthetic) and Total intravenous anesthesia in Anesthesia, sponsored by Università Vita-Salute San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Università Vita-Salute San Raffaele · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2005, registered Aug 2006).
Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Patients undergoing stenting procedures, or cardiac or non-cardiac surgery could develop myocardial damage as testified by cardiac troponin release.

Sevoflurane (volatile anesthetic), routinely used in cardiac and non-cardiac anesthesia, has cardioprotective properties that could be useful to reduce cardiac damage, as indicated by cardiac troponin release in different contexts:

  • stenting procedures (periprocedural administration)
  • non-cardiac surgery (during the whole procedure)
  • cardiac surgery (during the whole procedure)
Read the detailed description

Stenting procedures, cardiac and non-cardiac surgical procedures may carry a significant risk of cardiac damage ultimately leading to prolonged hospital stay and even a non-negligible periprocedural mortality rate. According to the American College of Cardiology/American Heart Association Guidelines all anesthetic techniques and drugs have known cardiac effects that should be considered in the perioperative plan. There appears to be no one best myocardium protective anesthetic technique: the choice of anesthesia is best left to the discretion of the anesthesia care team. To date no anesthesiological drug or techniques proved to reduce perioperative morbidity and mortality in cardiac surgery, only Beta-blockers and locoregional analgesia showed improved outcomes after non-cardiac surgery and no study on anesthesiological drugs has been performed in stenting procedures.

Volatile anesthetics, which are commonly used in general anesthesia to induce and maintain hypnosis, analgesia, amnesia and mild muscle relaxation, have been shown to improve post-ischemic recovery at the cellular level, in isolated hearts, and in animals, both through a pharmacological preconditioning and postconditioning action. Whether the cardioprotective effects of volatile anesthetics are clinically applicable and associated with improved cardiac function, ultimately resulting in a better outcome in patients undergoing cardiac surgery, is still debated. No data exist on patients undergoing non-cardiac surgery or stenting procedures.

A recently published meta-analysis including studies considering all volatile anesthetics showed no reduction in myocardial infarction and perioperative death rate. However the newer volatile anesthetics (desflurane and sevoflurane) seem to have more prominent cardioprotective properties and numerous apparently positive reports targeted to surrogate end-points, yet severely underpowered, have appeared in the literature. Of interest, many of these studies were not included in the above cited meta-analysis.

To address the question of whether the choice of an anesthetic regimen might influence patients' outcome we have planned a RCT to determine the impact of sevoflurane on perioperative cardiac damage in patients undergoing cardiac surgery, non-cardiac surgery and stenting procedures.

02

Conditions studied

  • Anesthesia

Keywords

  • Sevoflurane
  • Anesthesia
  • Troponin
  • Myocardial Preconditioning
  • Surgery, Cardiac
  • Stents
  • Non-cardiac Surgery
  • Surgery
03

In context

Lead sponsor

Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cardiac surgery
  • Non-cardiac surgery
  • Stenting procedures

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years old
  • Not signing written consent
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)

Study arms

  • Active comparator
    Total intravenous anesthesia

    Drug: Total intravenous anesthesia

  • Experimental
    sevoflurane

    Drug: Sevoflurane (Volatile Anesthetic)

Interventions

06

What researchers measure

Primary outcomes

  1. Reduce postprocedural cardiac troponin release

Secondary outcomes

  1. Reduce time on mechanical ventilation, Intensive Care Unit (ICU) and hospital stay

  2. mortality

07

Study locations

1 site
  • Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
    Milan, 20132, Italy
08

References and documents

Publications

  • Landoni G, Greco T, Biondi-Zoccai G, Nigro Neto C, Febres D, Pintaudi M, Pasin L, Cabrini L, Finco G, Zangrillo A. Anaesthetic drugs and survival: a Bayesian network meta-analysis of randomized trials in cardiac surgery. Br J Anaesth. 2013 Dec;111(6):886-96. doi: 10.1093/bja/aet231. Epub 2013 Jul 12. PubMed 23852263 ↗
  • Landoni G, Rodseth RN, Santini F, Ponschab M, Ruggeri L, Szekely A, Pasero D, Augoustides JG, Del Sarto PA, Krzych LJ, Corcione A, Slullitel A, Cabrini L, Le Manach Y, Almeida RM, Bignami E, Biondi-Zoccai G, Bove T, Caramelli F, Cariello C, Carpanese A, Clarizia L, Comis M, Conte M, Covello RD, De Santis V, Feltracco P, Giordano G, Pittarello D, Gottin L, Guarracino F, Morelli A, Musu M, Pala G, Pasin L, Pezzoli I, Paternoster G, Remedi R, Roasio A, Zucchetti M, Petrini F, Finco G, Ranieri M, Zangrillo A. Randomized evidence for reduction of perioperative mortality. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):764-72. doi: 10.1053/j.jvca.2012.04.018. Epub 2012 Jun 20. PubMed 22726656 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00364637
Lead sponsor
Università Vita-Salute San Raffaele
Responsible party
Giovanni Landoni (DM, Università Vita-Salute San Raffaele) — Principal investigator
First posted
Aug 15, 2006
Start date
Jan 2005
Primary completion
Aug 24, 2024
Completion
Sep 24, 2024
Last update
Feb 4, 2025

Study contacts

Giovanni Landoni, MD
principal investigator · Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Alberto Zangrillo, MD
study director · Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
View the source record on ClinicalTrials.gov ↗

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