Volatile Anesthetics in Cardiac Protection

Anesthesia Clinical Trial

Official title:

Pharmacological Preconditioning Properties of Volatile Anesthetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00364637
• Other study ID #: DS/URC/ER/mm 51/DG
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2005
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Giovanni Landoni, MD
• Phone: +39.347.2520801
• Email: landoni.giovanni[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Cardiac surgery

• Non-cardiac surgery

• Stenting procedures

Exclusion Criteria:

• Age < 18 years old

• Not signing written consent

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sevoflurane (Volatile Anesthetic)

• Total intravenous anesthesia

Locations

Country	Name	City	State
Italy	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce postprocedural cardiac troponin release
Secondary	Reduce time on mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
Secondary	mortality