AnesthesiaPhase 4NCT00364637
Volatile Anesthetics in Cardiac Protection
A Phase 4 study testing Sevoflurane (Volatile Anesthetic) and Total intravenous anesthesia in people with Anesthesia, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sevoflurane (Volatile Anesthetic) and Total intravenous anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2005to 24 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac surgery
- Non-cardiac surgery
- Stenting procedures
Who cannot join
- Age < 18 years old
- Not signing written consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milan, 20132
About this study
Official title: Pharmacological Preconditioning Properties of Volatile Anesthetics
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.
- Conditions
- Anesthesia
- Being tested
- Sevoflurane (Volatile Anesthetic), Total intravenous anesthesia
- Keywords
- Sevoflurane, Anesthesia, Troponin, Myocardial Preconditioning, Surgery, Cardiac, Stents, Non-cardiac Surgery, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane (Volatile Anesthetic)Drug
Total intravenous anesthesiaDrug
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia | Active comparator | Not described Receives: Drug: Total intravenous anesthesia |
| sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane (Volatile Anesthetic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce postprocedural cardiac troponin release
Secondary outcomes (2)
Reduce time on mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2005
- Primary completion24 Aug 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
- Investigators
- Giovanni Landoni, MD, Principal investigator, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, ItaliaAlberto Zangrillo, MD, Study director, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364637
- Sponsor's protocol ID
- DS/URC/ER/mm 51/DG
- Status last verified
- Jan 2025
- First submitted
- 11 Aug 2006
- Last updated
- 4 Feb 2025
- Results posted
- No
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 23852263Landoni 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Preconditioning Properties of Volatile Anesthetics
- ClinicalTrials.gov ID
- NCT00364637
- Acronym / sponsor ID
- DS/URC/ER/mm 51/DG
- Conditions
- Anesthesia
- Keywords
- Sevoflurane, Anesthesia, Troponin, Myocardial Preconditioning, Surgery, Cardiac, Stents, Non-cardiac Surgery, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia | Active comparator | Drug: Total intravenous anesthesia |
| sevoflurane | Experimental | Drug: Sevoflurane (Volatile Anesthetic) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cardiac surgery
- Non-cardiac surgery
- Stenting procedures
Key exclusion criteria (2 listed)
- Age < 18 years old
- Not signing written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane (Volatile Anesthetic) | Drug | sevoflurane |
| Total intravenous anesthesia | Drug | Total intravenous anesthesia |
Primary outcome
Reduce postprocedural cardiac troponin release
2 secondary outcomes
Reduce time on mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background: PubMed 23852263Landoni 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.
- Background: PubMed 22726656Landoni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane (Volatile Anesthetic) and Total intravenous anesthesia in people with Anesthesia, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce postprocedural cardiac troponin release. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00364637, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025; AzTrials last refreshed its copy on 4 Nov 2026.