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NCT Number: NCT03772106

Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery

Blood loss in hepatobiliary surgery is correlated with an increase in postoperative complications (e.g. transfusion related lung injury and tumor recurrence) and reduced longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological modulations are widely used to prevent blood loss. For pharmacological modulation central venous pressure is commonly used to reduce the pressure in the inferior vena cava, however little is known about pharmacological effect on blood flow in the hepatic artery and portal vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury due to low flow).

Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow. Propofol however, increases hepatic blood flow when compared with volatile anesthetics. Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion injury and survival of organs.

The aim of the study is to determine and to compare the effect of sevoflurane versus propofol on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

All patients receive standardized anesthesia care for hepato-biliary surgery according to the existing anesthesia protocol. The type of anaesthesia will be randomized : propolipid (TIV) or sevorane(inhalation).

At designated times, hemodynamic variables will be recorded.

These will include:

  • HF (/min)
  • CVP (mmHg),
  • MAP (mmHg)
  • CI (L/min.m2)
  • PPV (pulse pressure variation). Hemodynamic measurement will be done using PiCCO catheter.

The hemodynamic measurements will be compared and related to hepato-splanchnic blood flow and pressure measurements performed by the surgeon:

  • Flow v. porta
  • Flow art. hepatica
  • Pressure v. porta
  • Pressure v. cava The flow measurements will be done using ultrasound transit time flow measurements TTFM (Medi-Stim AS, Oslo, Norway).

At the same time pressure measurements will be obtained in portal vein and caval vein using a 25-gauge needle which is directly placed in the vein. Both flow and pressure will be simultaneously recorded (VeriQ 4122, Medi-Stim AS, Oslo, Norway). Both measurements will be done during apnea to minimize the effect of ventilation on pressure & flow. Flow values will be expressed in ml per minute, pressure values will be expressed in mmHg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult ≥ 18 years (Female or Male)
  • ASA I - II - III
  • Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
  • Scheduled for hepato-biliary surgery.

Exclusion criteria

  • Allergy for the medication
  • Renal insufficiency (SCr > 2 mg/dl)
  • Severe heart failure (EF < 25%)
  • Hemodynamic instable patients
  • Arterial fibrillation
  • Sepsis
  • BMI > 40
  • Severe coagulopathy (INR > 2)
  • Thrombocytopenia (< 80 x 10³ /µL)
  • History of severe postoperative nausea & vomiting

Treatment and study plan

Propofol Fresenius

Drug

Propolipid 1% : IV

sevorane

Drug

sevorane Quick fill (sevoflurane) : inhalation

Primary outcomes

  1. Change in blood flow in hepatic artery and main portal vein

    Time frame: From randomization until the end of the whipple surgery

    flow/pressure measurements with echo probe and needle

Secondary outcomes

  1. need of inotropic and/or vasopressor support

    Time frame: From start anesthesia until end of anesthesia

    total dose of inotropic and vasopressor medication that were used during surgery

  2. amount of blood loss

    Time frame: From start of surgery until end of surgery

    amount of blood loss at end of surgery

  3. amount of colloids given during surgery

    Time frame: From start of surgery until end of surgery

    total amount of colloids given during surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Dec 11, 2018

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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