Remote ischemic preconditioning in non-cardiac surgery (PRINCE study)
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
Pregnancy, locoregional anesthesia, ongoing or recent acute myocardial infarction (less than one month), cardiac surgery (BASEC)
Lieu de l’étude
Lugano, Zurich
(BASEC)
Sponsor
IRCSS Ospedale San Raffaele Milano, Italia
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Paolo Maino
+41(0)918117596
Paolo.Maino@cluttereoc.chServizio di Anestesiologia Ospedale Regionale di Lugano
(BASEC)
Informations générales
Vita-Salute University of Milan
(ICTRP)
Informations scientifiques
Vita-Salute University of Milan
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Tessin
(BASEC)
Date d'approbation du comité d'éthique
04.04.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT02427867 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Precondizionamento ischemico remoto in chirurgia non cardiaca (studio PRINCE) (BASEC)
Titre académique
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Titre public
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Maladie en cours d'investigation
Myocardial IschemiaSurgery (ICTRP)
Intervention étudiée
Other: Remote ischemic preconditioningOther: no ischemic preconditioning (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
cardiac troponin (ICTRP)
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Alberto Zangrillo, Prof., Vita-Salute University of Milan (ICTRP)
ID secondaires
PRINCE/43/OSR (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT02427867 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible