Remote ischemic preconditioning in non-cardiac surgery (PRINCE study)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Pregnancy, locoregional anesthesia, ongoing or recent acute myocardial infarction (less than one month), cardiac surgery (BASEC)
Studienstandort
Lugano, Zürich
(BASEC)
Sponsor
IRCSS Ospedale San Raffaele Milano, Italia
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Paolo Maino
+41(0)918117596
Paolo.Maino@cluttereoc.chServizio di Anestesiologia Ospedale Regionale di Lugano
(BASEC)
Allgemeine Auskünfte
Vita-Salute University of Milan
(ICTRP)
Wissenschaftliche Auskünfte
Vita-Salute University of Milan
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
04.04.2022
(BASEC)
ICTRP Studien-ID
NCT02427867 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Precondizionamento ischemico remoto in chirurgia non cardiaca (studio PRINCE) (BASEC)
Wissenschaftlicher Titel
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Öffentlicher Titel
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Untersuchte Krankheit(en)
Myocardial IschemiaSurgery (ICTRP)
Untersuchte Intervention
Other: Remote ischemic preconditioningOther: no ischemic preconditioning (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
cardiac troponin (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Alberto Zangrillo, Prof., Vita-Salute University of Milan (ICTRP)
Sekundäre IDs
PRINCE/43/OSR (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT02427867 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar