Hypotension
Conditions
Brief summary
This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery.
Interventions
OTHEROscillometric blood pressure monitoring at 2.5-minute intervals
Oscillometric blood pressure will be measured at 2.5-minute intervals during surgery.
OTHEROscillometric blood pressure monitoring at 5-minute intervals
Oscillometric blood pressure will be measured at 5-minute intervals during surgery.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥45 years * scheduled for elective non-cardiac surgery under general anesthesia * planned oscillometric blood pressure monitoring with an upper-arm cuff * American Society of Anesthesiologists physical status class II or higher
Exclusion criteria
* emergency surgery * arm or shoulder surgery * pregnancy * preoperative blood pressure differences between the right and left arm of more than 20 mmHg * intraoperative invasive blood pressure monitoring * previous preoperative peripheral nerve injury (such as diabetic neuropathy, carpal tunnel syndrome, or cervical radiculopathy) * contraindication for continuous finger-cuff blood pressure monitoring (e.g., Raynaud's disease, arterial-venous shunts, or cardiac assist devices)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average mean arterial pressure <65 mmHg | Beginning of surgery until the end of surgery | The primary endpoint will be the time-weighted average mean arterial pressure \<65 mmHg (continuous outcome) - defined as the area under a MAP of 65 mmHg divided by the time of continuous finger-cuff blood pressure monitoring \[mmHg\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of a mean arterial pressure <50 mmHg | Beginning of surgery until the end of surgery | Absolute number of patients with at least one 1-minute episode of a mean arterial pressure \<50 mmHg. |
| Norepinephrine dose | Beginning of surgery until the end of surgery | Time-weighted cumulative amount of norepinephrine indexed to body weight \[µg/kg/min\]. |
Countries
Germany
Outcome results
None listed