Remote ischemic preconditioning in non-cardiac surgery (PRINCE study)
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
Pregnancy, locoregional anesthesia, ongoing or recent acute myocardial infarction (less than one month), cardiac surgery (BASEC)
Trial sites
Lugano, Zurich
(BASEC)
Sponsor
IRCSS Ospedale San Raffaele Milano, Italia
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Paolo Maino
+41(0)918117596
Paolo.Maino@cluttereoc.chServizio di Anestesiologia Ospedale Regionale di Lugano
(BASEC)
General Information
Vita-Salute University of Milan
(ICTRP)
Scientific Information
Vita-Salute University of Milan
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Ticino
(BASEC)
Date of authorisation
04.04.2022
(BASEC)
ICTRP Trial ID
NCT02427867 (ICTRP)
Official title (approved by ethics committee)
Precondizionamento ischemico remoto in chirurgia non cardiaca (studio PRINCE) (BASEC)
Academic title
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Public title
Ischaemic PReconditioning In Non Cardiac surgEry (ICTRP)
Disease under investigation
Myocardial IschemiaSurgery (ICTRP)
Intervention under investigation
Other: Remote ischemic preconditioningOther: no ischemic preconditioning (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
cardiac troponin (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Alberto Zangrillo, Prof., Vita-Salute University of Milan (ICTRP)
Secondary trial IDs
PRINCE/43/OSR (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT02427867 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available