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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
210
In 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.
In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
RECRUITINGTime-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)
Time frame: From the start of surgery until the end of surgery
Area under a MAP <65 mmHg
Area under a MAP \<65 mmHg \[mmHg min\] (continuous endpoint)
Time frame: From the start of surgery until the end of surgery
Total duration of MAP <65 mmHg
Total duration of MAP \<65 mmHg \[min\] (continuous endpoint)
Time frame: From the start of surgery until the end of surgery
Number of discrete hypotensive episodes
Number of discrete hypotensive episodes, defined as MAP \<65 mmHg sustained for \>1 min (count endpoint)
Time frame: From the start of surgery until the end of surgery
Area above a MAP >100 mmHg
Area above a MAP \>100 mmHg \[mmHg min\] (continuous endpoint)
Time frame: From the start of surgery until the end of surgery
Time-weighted average MAP >100 mmHg
Time-weighted average MAP \>100 mmHg \[mmHg\], calculated from randomization until the end of surgery (continuous endpoint)
Time frame: From the start of surgery until the end of surgery
Average norepinephrine infusion rate
Average norepinephrine infusion rate \[μg kg-1 min-1\] (continuous endpoint)
Time frame: From the start of surgery until the end of surgery
Bernd Saugel
CONTACT
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Total volume of administered crystalloids
Total volume of administered crystalloids \[ml\] (continuous endpoint)
Time frame: From the start of surgery until the end of surgery