The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.
male patient ≥18 years
scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
planned intraarterial blood pressure monitoring
patients in whom the attending anesthesiologist considers intraarterial blood pressure monitoring to be mandatory for clinical reasons
patients participating in another interventional trial likely to influence intraoperative blood pressure management
Parallel
Oscillometric blood pressure monitoring
Other interventionIn patients assigned to oscillometric blood pressure monitoring, clinicians will be blinded to intraarterial blood pressure monitoring and intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring at 2.5-minute intervals.
Intraarterial blood pressure monitoring
Other interventionIn patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.
Time-weighted average MAP <65 mmHg
Time-weighted average MAP \<65 mmHg \[mmHg\], calculated from the start of surgery until the end of surgery (continuous endpoint)
Area under a MAP <65 mmHg
Area under a MAP \<65 mmHg \[mmHg min\] (continuous endpoint)
Total duration of MAP <65 mmHg
Total duration of MAP \<65 mmHg \[min\] (continuous endpoint)
Number of discrete hypotensive episodes
Number of discrete hypotensive episodes, defined as MAP \<65 mmHg sustained for \>1 min (count endpoint)
Area above a MAP >100 mmHg
Area above a MAP \>100 mmHg \[mmHg min\] (continuous endpoint)
Incidence of a composite binary outcome defined as the occurrence of at least one of the following: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death
Incidence of a composite binary outcome defined as the occurrence of at least one of the following within the first 30 postoperative days: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death (binary endpoint)
Incidence of need for renal replacement therapy
Incidence of need for renal replacement therapy within the first 30 postoperative days (binary endpoint)
Incidence of myocardial infarction
Incidence of myocardial infarction within the first 30 postoperative days (binary endpoint)
Incidence of non-fatal cardiac arrest
Incidence of non-fatal cardiac arrest within the first 30 postoperative days (binary endpoint)
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