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Completed

NCT Number: NCT06950606

Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery

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

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Key information

Conditions

Hypotension During Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria:

  • Surgery in which pneumatic calve compression is indicated according to ERAS guidelines
  • Surgery which interferes with the installation or correct function of PLC
  • Sepsis (according to current Sepsis-3 definition)
  • Pregnancy
  • Congestive heart failure NYHA III/IV
  • American Society of Anesthesiologists (ASA) physical status classification V or VI
  • Interference of PLC and patient positioning (e.g.; extreme Trendelenburg positioning, lithotomy positioning)
  • Contraindications for the use of PLC according to the German guideline13 (e.g., extensive thrombophlebitis, thrombosis or suspected thrombosis of the lower limbs, erysipelas, acute phlegmon, limb compartment syndrome, severe uncontrolled arterial hypertension, lymphatic drainage disorder proximal to PLC, extensive open soft tissue trauma, autoimmune blistering skin conditions such as IgA bullous dermatosis or bullous pemphigoid)

Treatment and study plan

Pneumatic leg compression

Device

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

Primary outcomes

  1. Average norepinephrine infusion rate

    Time frame: 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 outcomes

  1. Average norepinephrine infusion rate

    Time frame: Perioperative

    Average norepinephrine infusion rate [μg kg-1 min-1] needed to keep MAP above 65mmHg. (continuous outcome)

  2. Amount of hypotensive events

    Time frame: Intraoperative

    Amount of hypotensive events with a MAP <65 [mmHg]

  3. Lowest MAP

    Time frame: Intraoperative

    Lowest MAP [mmHg]

  4. Cumulative amount of hypotensive time

    Time frame: Intraoperative

    Cumulative amount of hypotensive time with a MAP <65 mmHg [min]

  5. Time-weighted average MAP <65 mmHg

    Time frame: Perioperative

    Time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the time from the beginning of induction of general anesthesia until the end) [mmHg]

  6. Crystalloid fluid application

    Time frame: Intraoperative

    Amount of crystalloid fluid application [ml]

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial

Acronym: PLANE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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