Hypotension During Surgery
Conditions
Keywords
Stressed volume, Vasopressor
Brief summary
The PLANE trial is a randomized, single-center trial investigating whether pneumatic leg compression reduces the amount of norepinephrine needed to keep MAP above 65mmHg compared to routine care without PLC in patients having non-cardiac surgery under general anesthesia
Interventions
DEVICEPneumatic leg compression
Patients assigned to the PLC group will receive a pneumatic leg compression sleeve encompassing the calf and thigh, with sleeve size adjusted according to thigh circumference and manufacturer recommendations. The compression pump will be activated before the start of surgery. After surgery, the responsible trial personnel will deactivate the pump and remove the compression sleeves in the PLC group. There will be no standardized anesthesia management protocol; all decisions regarding hemodynamic management will be made at the discretion of the treating anesthesiologist
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes
Exclusion criteria
Patients with the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average norepinephrine infusion rate | Intraoperative | Average intraoperative norepinephrine infusion rate \[μg kg-1 min-1\] needed to keep MAP above 65mmHg. The average intraoperative norepinephrine infusion rate will be calculated using the absolute amount of norepinephrine administered per kg bodyweight \[μg kg-1\] divided by the duration of surgery (between surgical incision and suture) \[min\] (continuous outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lowest intraoperative MAP [mmHg] | Intraoperative | Lowest intraoperative MAP \[mmHg\] |
| Cumulative intraoperative time with MAP <65 mmHg [min] | Intraoperative | Cumulative intraoperative time with MAP \<65 mmHg \[min\] |
| Intraoperative area under a MAP of 65 mmHg | Intraoperative | Intraoperative area under a MAP of 65 mmHg |
| Intraoperative time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time) | Intraoperative | Intraoperative time-weighted average MAP \<65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time) |
| Volume of crystalloid fluid given during surgery [ml] | Intraoperative | Volume of crystalloid fluid given during surgery \[ml\] |
Countries
Germany
Outcome results
None listed