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Recruiting NCT07349186

Oscillometric Versus Intraarterial Blood Pressure Monitoring During Robot-Assisted Prostatectomy

No phase Interventional Intraoperative Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oscillometric blood pressure monitoring, Intraarterial blood pressure monitoring.
Who it may be relevant to
Registry conditions: Intraoperative Hypotension. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial

Overview

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

  • Other Oscillometric 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.
  • Other Intraarterial 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.

Primary outcome measures

  • Time-weighted average MAP <65 mmHg [Time frame: From the start of surgery until the end of surgery]
Secondary outcome measures (7)
  • Area under a MAP <65 mmHg [Time frame: From the start of surgery until the end of surgery]
  • Total duration of MAP <65 mmHg [Time frame: From the start of surgery until the end of surgery]
  • Number of discrete hypotensive episodes [Time frame: From the start of surgery until the end of surgery]
  • Area above a MAP >100 mmHg [Time frame: From the start of surgery until the end of surgery]
  • Time-weighted average MAP >100 mmHg [Time frame: From the start of surgery until the end of surgery]
  • Average norepinephrine infusion rate [Time frame: From the start of surgery until the end of surgery]
  • Total volume of administered crystalloids [Time frame: From the start of surgery until the end of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Medical Center Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT07349186 · 2025-101598-BOff

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗