Remote ischemic preconditioning in non-cardiac surgery (PRINCE study)
Descrizione riassuntiva dello studio
The aim of the study is to verify whether the inflation-deflation procedure of the blood pressure cuff performed immediately after the induction of general anesthesia (this procedure is called remote ischemic preconditioning) during non-cardiac surgery at medium and high risk can reduce cardiac damage and the incidence of adverse events in the postoperative period. The participant will be randomly assigned to one of the two study groups. One group will undergo 3 cycles of inflation-deflation of the blood pressure cuff immediately after the induction of general anesthesia. Each cycle consists of 5 minutes of inflation followed by 5 minutes of deflation. The other group, however, will not undergo the inflation-deflation procedure of the blood pressure cuff (control). Neither the participant nor the study staff, except for the anesthetist performing the procedure, will know which group the participant is assigned to. In addition to the normal hematochemical checks and the normal assessments required for the surgical procedure according to standard procedures, the participant will undergo measurement of troponin (a substance released in case of cardiac damage) and an electrocardiogram (ECG) before and after the surgical intervention. The participant will be followed before, during, and after the surgical intervention until discharge from the hospital. A telephone check on health status is planned 30 days and 1 year after the surgical intervention.
(BASEC)
Intervento studiato
Experimental group (inflation-deflation procedure of the blood pressure cuff): the blood pressure cuff will be placed on one arm (or leg) immediately after the induction of general anesthesia and will be inflated for 5 minutes followed by 5 minutes of deflation. This procedure will be performed 3 times.
Control group: no inflation-deflation procedure of the blood pressure cuff. The blood pressure cuff will be placed on one arm (or leg) but will not be inflated or deflated.
(BASEC)
Malattie studiate
Non-cardiac surgical intervention at medium and high risk under standard general anesthesia
(BASEC)
Patients over 50 years old undergoing a non-cardiac surgical intervention at medium and high risk under general anesthesia. (BASEC)
Criteri di esclusione
Pregnancy, locoregional anesthesia, ongoing or recent acute myocardial infarction (less than one month), cardiac surgery (BASEC)
Luogo dello studio
Lugano, Zurigo
(BASEC)
Sponsor
IRCSS Ospedale San Raffaele Milano, Italia
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Paolo Maino
+41(0)918117596
Paolo.Maino@cluttereoc.chServizio di Anestesiologia Ospedale Regionale di Lugano
(BASEC)
Informazioni generali
Vita-Salute University of Milan
(ICTRP)
Informazioni scientifiche
Vita-Salute University of Milan
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
04.04.2022
(BASEC)
ID di studio ICTRP
NCT02427867 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Precondizionamento ischemico remoto in chirurgia non cardiaca (studio PRINCE) (BASEC)
Titolo accademico
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Titolo pubblico
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Malattie studiate
Myocardial IschemiaSurgery (ICTRP)
Intervento studiato
Other: Remote ischemic preconditioningOther: no ischemic preconditioning (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- written informed consent
- intermedial and high risk non cardiac surgery
- general anesthesia
- ongoing or recently suspended antiplatelet therapy
Exclusion Criteria:
- pregnancy
- planned locoregional anesthesia without general anesthesia
- unstable or ongoing angina
- recent (< 1 month) or ongoing acute myocardial infarction
- inclusion in other randomised controlled studies in the previous 30 days
- peripheral vascular disease affecting the upper limbs
- cardiac surgery (ICTRP)
non disponibile
Endpoint primari e secondari
cardiac troponin (ICTRP)
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Alberto Zangrillo, Prof., Vita-Salute University of Milan (ICTRP)
ID secondari
PRINCE/43/OSR (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT02427867 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile