NCT00364637

Brief 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)

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2024

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

19.7 years

First QC Date

August 11, 2006

Last Update Submit

January 31, 2025

Conditions

Anesthesia

Keywords

SevofluraneAnesthesiaTroponinMyocardial PreconditioningSurgery, CardiacStentsNon-cardiac SurgerySurgery

Outcome Measures

Primary Outcomes (1)

  • Reduce postprocedural cardiac troponin release

Secondary Outcomes (2)

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

  • mortality

Study Arms (2)

Total intravenous anesthesia

ACTIVE COMPARATOR
Drug: Total intravenous anesthesia

sevoflurane

EXPERIMENTAL
Drug: Sevoflurane (Volatile Anesthetic)

Interventions

Sevoflurane (Volatile Anesthetic)DRUG
sevoflurane
Total intravenous anesthesiaDRUG
Total intravenous anesthesia

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac surgery
  • Non-cardiac surgery
  • Stenting procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Milan, 20132, Italy

Location

Related Publications (2)

  • 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.

    PMID: 23852263BACKGROUND

  • 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.

    PMID: 22726656BACKGROUND

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Giovanni Landoni, MD

    Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

    PRINCIPAL INVESTIGATOR

  • Alberto Zangrillo, MD

    Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

January 1, 2005

Primary Completion

August 24, 2024

Study Completion

September 24, 2024

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations

IT(1)