Intraoperative Hypotension
Conditions
Brief summary
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.
Interventions
OTHEROscillometric blood pressure monitoring
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.
OTHERIntraarterial blood pressure monitoring
In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.
Sponsors
University of Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male patient ≥18 years * scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position * planned intraarterial blood pressure monitoring
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average MAP <65 mmHg | From the start of surgery until the end of surgery | Time-weighted average MAP \<65 mmHg \[mmHg\], calculated from the start of surgery until the end of surgery (continuous endpoint) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under a MAP <65 mmHg | From the start of surgery until the end of surgery | Area under a MAP \<65 mmHg \[mmHg min\] (continuous endpoint) |
| Total duration of MAP <65 mmHg | From the start of surgery until the end of surgery | Total duration of MAP \<65 mmHg \[min\] (continuous endpoint) |
| Number of discrete hypotensive episodes | From the start of surgery until the end of surgery | Number of discrete hypotensive episodes, defined as MAP \<65 mmHg sustained for \>1 min (count endpoint) |
| Area above a MAP >100 mmHg | From the start of surgery until the end of surgery | Area above a MAP \>100 mmHg \[mmHg min\] (continuous endpoint) |
| Time-weighted average MAP >100 mmHg | From the start of surgery until the end of surgery | Time-weighted average MAP \>100 mmHg \[mmHg\], calculated from randomization until the end of surgery (continuous endpoint) |
| Average norepinephrine infusion rate | From the start of surgery until the end of surgery | Average norepinephrine infusion rate \[μg kg-1 min-1\] (continuous endpoint) |
| Total volume of administered crystalloids | From the start of surgery until the end of surgery | Total volume of administered crystalloids \[ml\] (continuous endpoint) |
Countries
Germany
Contacts
CONTACTAlina Bergholz
CONTACTBernd Saugel
Outcome results
None listed